System and Method for High Density Electrode Management

ABSTRACT

Systems, devices and methods for advanced electrode management in neurological monitoring applications include receiving sockets configured to receive connectors having groups of electrodes. The physician is not required to manually map each electrode with its corresponding input channel. Electrodes are coupled to the corresponding input channels in groups through connectors having a unique identification (ID). The system is configured to read the unique ID of each connector and establish its identity. Based on the ID, the system configures itself to automatically correlate or associate each electrode with its corresponding input channel when the connectors are first inserted into the receiving sockets, and again if the connectors are removed and re-inserted into different positions in the receiving sockets, to insure the electrodes are always mapped to the same input channels.

CROSS-REFERENCE

The present application relies on U.S. Patent Provisional ApplicationNo. 62/774,042, entitled “System and Method for High Density ElectrodeManagement” and filed on Nov. 30, 2018, which is herein incorporated byreference in its entirety.

In addition, the present application is a continuation-in-partapplication of U.S. patent application Ser. No. 16/267,689, entitled“System and Method for High Density Electrode Management” and filed onFeb. 5, 2019, which, in turn, is a continuation of U.S. patentapplication Ser. No. 15/376,655, entitled “System and Method for HighDensity Electrode Management”, filed on Dec. 12, 2016, and issued asU.S. Pat. No. 10,238,467 on Mar. 26, 2019, all of which are hereinincorporated by reference in their entirety.

FIELD

The present specification generally relates to the field ofneuro-monitoring applications and more specifically to a system andmethod for managing a large number of electrodes in such applications.

BACKGROUND

Several medical procedures involve deploying multiple sensors on thehuman body for the recording and monitoring of data required for patientcare. Information, such as vital health parameters, cardiac activity,bio-chemical activity, electrical activity in the brain, gastricactivity and physiological data, is usually recorded through on-body orimplanted sensors/electrodes which are controlled through a wired orwireless link. Typical patient monitoring systems comprise a controlunit connected through a wire to one or more electrodes coupled to thespecific body parts of the patient. In some applications, such as withpulse oximeter or EKG (electrocardiograph) devices, the electrodescoupled to the body are easily managed as there are not too many (fewernumber of electrodes). However, with applications that require a largenumber of electrodes to be coupled to the human body, the overall setup, placement and management of electrodes is a cumbersome process.

Neuromonitoring includes the use of electrophysiological methods, suchas electroencephalography (EEG), electromyography (EMG), and evokedpotentials, to monitor the functional integrity of certain neuralstructures (e.g., nerves, spinal cord and parts of the brain) duringsurgery. The purpose of neuromonitoring is to reduce the risk to thepatient of iatrogenic damage to the nervous system, and/or to providefunctional guidance to the surgeon and anesthesiologist.Neurodiagnostics includes the use of electrophysiological methods, suchas electroencephalography (EEG), electromyography (EMG), polysomnography(PSG) and evoked potentials, to diagnose the functional integrity ofcertain neural structures (e.g., nerves, spinal cord and parts of thebrain) to assess disease states and determine potential therapy ortreatment. Generally, neuromonitoring and neurodiagnostic procedures mayinvolve a large number of electrodes coupled to the human body. Forexample, in an EEG procedure, the electrodes are used to record andmonitor the electrical activity corresponding to various parts of thebrain for detection and treatment of various ailments such as epilepsy,sleep disorders and coma. EEG procedures are either non-invasive orinvasive. In non-invasive EEG, a number of electrodes are deployed onthe human scalp for recording electrical activity in portions of theunderlying brain. In invasive EEG, through surgical intervention, theelectrodes are placed directly over sections of the brain, in the formof a strip or grid, or are positioned in the deeper areas of the brain,in the form of depth electrodes. Each of these electrodes is coupled toa wire lead which, in turn, is connected to a control unit adapted toreceive and transmit electrical signals. The electrical activity patterncaptured by various electrodes is analyzed using standard algorithms tolocalize or spot the portion of brain which is responsible for causingthe specific ailment.

While EEG is a stand-alone product and medical discipline, it can beused as a component of neuromonitoring, for example, in the operatingroom for neuromonitoring during surgery. EEG may also be used in anin-patient setting such as an epilepsy monitoring unit (EMU). In thecase of monitoring in an EMU, a patient will undergo surgery to placestrip, grid, or depth electrodes on or in the brain and then remain in ahospital room under observation for 7-10 days. During this time, thepatient will be taken off of their epilepsy medications and anyresulting seizures recorded. This is potentially dangerous to thepatient which necessitates constant medical observation. Once theaffected area of the brain is identified for removal or treatment, asecond surgical procedure is performed to either remove the focal pointof the seizures or to implant a device to help stop the seizures.

The number of electrodes in EEG systems typically varies between 21 and256 and can be over 500. Increasing the number of electrodes in EEGprocedures helps decrease the localization error and thus more ablyassist the physician to better plan for surgical procedures.Accordingly, advanced EEG systems involve electrode configurations toseparately map the electrical activity corresponding to many portions ofthe brain. However, the overall set up and verification process forthese advanced EEG systems becomes more time consuming and error proneas the number of electrodes increases in the EEG procedures.

In neuromonitoring and neurodiagnostics, as each electrode is positionedat a different location to capture the electrical activity in itsvicinity, the input recorded from each electrode has to be processedindependently. The system is required to recognize the identity of eachelectrode and accordingly process the input received from thatelectrode. To achieve this, it is important that each electrode iscoupled to the correct input channel in the control unit of theneuromonitoring or neurodiagnostics system. However, in practicalscenarios, it is possible that, while connecting a large number ofelectrodes to respective input channels, the medical care providerconnects an electrode to a wrong input channel. This could result inmaking the entire process faulty. Therefore, in high density electrodeconfigurations, the set up process is time consuming as the connectioncorresponding to each electrode needs to be separately established andthen verified for integrity before starting the procedure. In practice,the time required to set up and verify large numbers of connecting leadsprevents following the best practice of checking all electrodes andverifying their integrity before starting the procedure and hencecompromises the quality of medical care.

Surgical applications in EEG also use strip, grid and depth electrodearrays (and other electrode geometries) which typically combine multipleunique conductive elements into a pattern placed within a substratematerial and then placed in contact with the brain. Lead wires connectedto each conductive element are grouped into cables (from 1 to 4 or moredepending on the size of the electrode array) attached to the electrodeand typically terminate in one connector per cable with each cablecontaining 4 or more lead wires. Each connector is attached to anadapter with typically 4 or more individual leads, each leadcorresponding to a unique element on the electrode, and then to anamplifier that has inputs for each individual channel. However, when apatient is monitored with an EEG system having, for example, 200+electrodes, even grouping these electrodes results in more than a dozenadapters and the connections corresponding to these adapters needs to beindividually verified every time before starting a procedure.

Therefore, the current neuromonitoring and neurodiagnostics medicaldevices involving a large number of electrodes do not provide an easyand convenient way for physicians to deploy such systems. These systemssuffer from significant risk of unreliable measurements due to incorrectconnections. There is significant risk of error in deploying suchsystems. Further, deployment of such systems is time consuming whichprevents following the best practices and therefore compromises thequality of medical care.

Devices and systems are required which are convenient to use, do notconsume too much time for deployment, and reduce the risk ofconfiguration error. Such devices and systems should automaticallyrecognize the position or identity of various electrodes and associatethe electrodes with a specific input channel, thereby not requiring thephysician to manually map each electrode with a specific input channel.Such devices would reduce the complexity of the large number ofconnections, reduce connection errors, and reduce the time to connectand configure the monitoring systems. The devices would also streamlineworkflow around patient care and system configuration and enhance theserviceability of neuromonitoring and neurodiagnostics products.

SUMMARY

The present specification discloses a system for neuromonitoringcomprising: a plurality of electrode groups, wherein each group of theplurality of electrode groups comprises electrodes, wherein each of theelectrodes in each group has at least one of a similar monitoringfunctionality type or a similar deployment location and wherein each ofthe plurality of electrode groups has at least one electrode group lead;a plurality of connectors, wherein each of the at least one electrodegroup leads is coupled to at least one connector of the plurality ofconnectors and wherein each of the electrode group leads and/or each ofconnectors of the plurality of connectors are electronically associatedwith a unique identification code; and, a control unit comprising atleast one receiving unit configured for receiving the plurality ofconnectors, wherein the control unit is configured to determine at leastone of the unique identification code of each connector of the pluralityof connectors or the unique identification code of each of the at leastone electrode group leads and to associate each electrode in theplurality of electrode groups with a corresponding input channel in thecontrol unit based on at least one of the unique identification code ofeach connector or the unique identification code of each of the at leastone electrode group leads.

The unique identification code may be in a 128 bit GUID format.

The at least one receiving unit may comprise a plurality of inputsockets configured to receive one or more connectors of said pluralityof connectors. The one or more connectors may be configured to becoupled to any of the plurality of input sockets of said at least onereceiving unit.

Optionally, the control unit is configured to determine at least one ofthe unique identification code of each connector of the plurality ofconnectors or the unique identification code of each of the at least oneelectrode group leads by receiving, via each connector of the pluralityof connectors, data indicative of at least one of the uniqueidentification code of each connector of the plurality of connectors orthe unique identification code of each of the at least one electrodegroup leads.

Optionally, the control unit is configured to receive, via eachconnector of the plurality of connectors, data indicative of at leastone of the unique identification code of each connector of the pluralityof connectors or the unique identification code of each of the at leastone electrode group leads through a direct pin-to-pin electrical passthrough.

Optionally, the control unit is configured to determine at least one ofthe unique identification code of each connector of the plurality ofconnectors or the unique identification code of each of the at least oneelectrode group leads by receiving, via at least one connector of theplurality of connectors, data indicative of at least one of the uniqueidentification code of each connector of the plurality of connectors orthe unique identification code of each of the at least one electrodegroup leads.

Optionally, the control unit is configured to receive, via eachconnector of the plurality of connectors, data indicative of at leastone of a production date or authentication data.

Optionally, the control unit is configured to receive, via eachconnector of the plurality of connectors and through a direct pin-to-pinelectrical pass through, data indicative of at least one of a productiondate of the plurality of connectors or the electrodes or authenticationdata.

The connector may have a designated output pin which is configured totransmit information related to the unique identification code to saidcontrol unit. Data indicative of the unique identification code may bestored in a memory associated with the designated output pin.

Data indicative of the unique identification code may comprise a barcode or a radio frequency code (RFID).

Data indicative of the unique identification code may be stored using atleast one pin configured as at least one dip switch comprising at leastone resistor.

Optionally, each connector of the plurality of connectors is configuredto be inserted in the at least one receiving unit in at least twodifferent orientations.

Optionally, each connector of the plurality of connectors comprises atleast two designated output pins, each of which being configured toconvey data indicative of the unique identification code and anorientation of a connector of the plurality of connectors. Optionally,the at least two designated output pins are configured to be atdifferent polarities or at different voltage levels to indicate theorientation of the connector of the plurality of connectors. Optionally,a physical position of the at least two designated output pins isdifferent in each of the at least two different orientations.

Optionally, the system further comprises a rigid connector plate,wherein the connector plate comprises a plurality of openings, eachopening of the plurality of openings being configured to receive eachconnector of the plurality of connectors, and wherein each opening ofthe plurality of openings is separated from an adjacent opening of theplurality of openings by a portion of the connector plate. Optionally,each connector of the plurality of connectors is partially positioned ineach opening of the plurality of openings such that a first end of eachconnector extends outward from a first surface of the connector plateand a second end, opposing the first end, of each connector extendsoutward from a second surface of the connector plate, wherein the secondsurface opposes the first surface.

Optionally, the system further comprises a rigid connector plate,wherein the connector plate comprises a plurality of sockets, eachsocket of the plurality of sockets being configured to receive eachconnector of the plurality of connectors, and wherein each socket of theplurality of sockets is separated from an adjacent socket of theplurality of sockets by a portion of the connector plate and isconfigured to electrically connect to a corresponding socket in the atleast one receiving unit.

Optionally, the control unit is further configured to determine at leastone of authentication data or data indicative of a production date ofthe plurality of connectors or the electrodes by receiving, via at leastone connector of the plurality of connectors, data indicative of the atleast one of authentication data or data indicative of the productiondates of the plurality of connectors or the electrodes.

Optionally, the control unit is configured to generate data indicativeof, or associated with, a three-dimensional image. The three-dimensionalimage may comprise a plurality of pixel positions and wherein at leastone of the plurality of pixel positions is associated, in a memory, withat least one of the electrodes. Optionally, the control unit isconfigured to receive data indicative of a user input selecting at leastone of the plurality of pixel positions of the three-dimensional imageand is configured to identify at least one electrode associated with theselected at least one of the plurality of pixel positions based on theuser input. Optionally, the control unit is further configured todetermine data associated with the identified at least one electrode byusing the unique identification code associated with the at least oneelectrode.

Optionally, the control unit is configured to automatically populate atleast one graphical user interface with data indicative representativeof each of the electrodes based on the unique identification codes.Optionally, the control unit is configured to automatically update datadisplayed in the at least one graphical user interface with updated dataindicative representative of each of the electrodes based on the uniqueidentification codes after one or more of the electrodes is moved ordisconnected and reconnected to the at least one receiving unit.

Optionally, the control unit is configured to receive data indicative ofa user selection of a trace displayed on a graphical user interface,wherein, upon receiving data indicative of the user selection of thetrace, the control unit is configured to trigger a visual indicatorpositioned in physical proximity to or association with one of theelectrodes that acquired data associated with said trace. Optionally,the visual indicator is at least one of a light positioned on the one ofthe electrodes, a light positioned on a connector of the plurality ofconnectors in data communication with the one of the electrodes, or alight positioned on a lead attached to the one of the electrodes.

Optionally, the electrodes are configured in groups of 4, 5, 6, 7, 8, 9,10, 11, 12, 13, 14, 15 or 16 electrodes.

Optionally, the system is configured to perform at least one of anelectroencephalography, electrocardiogram, electromyography,polysomnography, or intraoperative neural monitoring procedure.

The unique identification code associated with each said electrode grouplead may be stored in association with each electrode group lead,wherein the unique identification code is configured as any one of acrimp, an adhesive label or an embedded code on each electrode grouplead.

Optionally, each connector of the plurality of connectors furthercomprises a value wherein the value is representative of a number ofpermissible uses of the connector of the plurality of connectors. Thevalue may be indicative of a maximum number of sterilization cycles ofthe connector of the plurality of connectors wherein the maximum numberof sterilization cycles is equal to, or less than, 20.

Optionally, the control unit is configured to access a value associatedwith each connector of the plurality of connectors, wherein the value isindicative of a maximum number of sterilization cycles of the connectorof the plurality of connectors wherein the maximum number ofsterilization cycles is equal to, or less than, 20.

The present specification also discloses a method for neuromonitoring orneurodiagnostics comprising: acquiring a plurality of electrode groups,wherein each group of the plurality of electrode groups compriseselectrodes, wherein each of the electrodes in each group has a similarmonitoring functionality type and/or a similar deployment location andwherein each of the plurality of electrode groups has at least oneelectrode group lead; coupling each of the at least one electrode groupleads to a connector of a plurality of connectors, wherein each of theat least one electrode group leads and/or each connector of theplurality of connectors is electronically associated with a uniqueidentification code; coupling each connector of the plurality ofconnectors to a socket in a control unit; using the control unit,determining at least one of the unique identification code of eachconnector of the plurality of connectors or the unique identificationcode of each of the at least one electrode group leads; and using thecontrol unit, associating each electrode in the plurality of electrodegroups with a corresponding input channel in the control unit based onat least one of the unique identification code of each connector or theunique identification code of each of the at least one electrode groupleads, such that each electrode in the plurality of electrode groups isuniquely associated with only one input channel in the control unit.

The unique identification code may be in a 128 bit GUID format.

Optionally, determining at least one of the unique identification codeof each connector of the plurality of connectors or the uniqueidentification code of each of the at least one electrode group leads isexecuted in the control unit by receiving, via each connector of theplurality of connectors, data indicative of at least one of the uniqueidentification code of each connector of the plurality of connectors orthe unique identification code of each of the at least one electrodegroup leads.

Optionally, the method further comprises receiving, in the control unitand via each connector of the plurality of connectors through a directpin-to-pin electrical pass through, data indicative of at least one ofthe unique identification code of each connector of the plurality ofconnectors or the unique identification code of each of the at least oneelectrode group leads.

Optionally, the method further comprises receiving, in the control unitand via each connector of the plurality of connectors through a directpin-to-pin electrical pass through, data indicative of at least one of aproduction date of the plurality of connectors, a production date of theelectrodes, or authentication information.

Each connector may comprise a designated output pin wherein thedesignated output pin is configured to transfer information related tothe unique identification code to the control unit.

Data indicative of the unique identification code may be stored in amemory associated with the designated output pin.

Data indicative of the unique identification code may comprise a barcode or a radio frequency code (RFID).

Data indicative of the unique identification code may be stored using atleast one pin configured as at least one dip switch comprising at leastone resistor.

Each connector of the plurality of connectors may be configured to beinserted in the control unit in at least two different orientations.

Optionally, each connector of the plurality of connectors comprises atleast two designated output pins, each of which being configured toconvey data indicative of the unique identification code and anorientation of a connector of the plurality of connectors. Optionally,the at least two designated output pins are configured to be atdifferent polarities or at different voltage levels to indicate theorientation of the connector of the plurality of connectors. Optionally,a physical position of the at least two designated output pins isdifferent in each of the at least two different orientations.

Optionally, the method further comprises inserting each connector of theplurality of connectors into an opening in a rigid connector plate andconcurrently inserting each connector of the plurality of connectorsinto corresponding sockets in the control unit by pushing the connectorplate toward the control unit. Optionally, the method further comprisespartially positioning each connector of the plurality of connectors ineach opening such that a first end of each connector extends outwardfrom a first surface of the connector plate and a second end, opposingthe first end, of each connector extends outward from a second surfaceof the connector plate, wherein the second surface opposes the firstsurface.

Optionally, the method further comprises inserting each connector of theplurality of connectors into a corresponding socket in a rigid connectorplate, wherein each corresponding socket has a first end configured toconnect to a connector of the plurality of connectors and a second endconfigured to connect to a corresponding socket in the control unit, andconcurrently placing each connector of the plurality of connectors intoelectrical communication with the control unit by pushing the connectorplate toward the control unit such that the second end of each socket isplaced into electrical communication with each corresponding socket inthe control unit.

Optionally, the method further comprises receiving, into the controlunit and via at least one connector of the plurality of connectors, dataindicative of at least one of authentication data or data indicative ofthe production dates of the plurality of connectors or the electrodesand determining, using the control unit, at least one of authenticationdata or data indicative of a production date of the plurality ofconnectors or the electrodes.

Optionally, the method further comprises, using the control unit,generating data indicative of, or associated with, a three-dimensionalimage. The three-dimensional image may comprise a plurality of pixelpositions wherein at least one of the plurality of pixel positions isassociated, in a memory, with at least one of the electrodes.Optionally, the method further comprises receiving, in the control unit,data indicative of a user input selecting at least one of the pluralityof pixel positions of the three-dimensional image and, using the controlunit, identifying at least one electrode associated with the selected atleast one of the plurality of pixel positions based on the user input.Optionally, the method further comprises determining trace dataassociated with the identified at least one electrode by using theunique identification code associated with the at least one electrode.

Optionally, the method further comprises automatically populating atleast one graphical user interface with data indicative representativeof each of the electrodes based on the unique identification codes.Optionally, the method further comprises automatically updating datadisplayed in the at least one graphical user interface with updated dataindicative representative of each of the electrodes based on the uniqueidentification codes after one or more of the electrodes is moved ordisconnected and reconnected to the control unit.

Optionally, the method further comprises receiving, in the control unit,data indicative of a user selection of a trace displayed on a graphicaluser interface, wherein, upon receiving data indicative of the userselection of the trace, triggering a visual indicator positioned inphysical proximity to or association with one of the electrodes thatacquired data associated with said trace. The visual indicator may be atleast one of a light positioned on the one of the electrodes, a lightpositioned on a connector of the plurality of connectors in datacommunication with the one of the electrodes, or a light positioned on alead attached to the one of the electrodes.

Optionally, the method further comprises coupling each of the electrodegroup leads to each of the connectors in a predefined order.

Optionally, the electrodes are configured in groups of 4, 5, 6, 7, 8, 9,10, 11, 12, 13, 14, 15 or 16 electrodes.

Optionally, the method further comprises performing at least one of anelectroencephalography, electrocardiogram, electromyography,polysomnography, or intraoperative neural monitoring procedure.

Optionally, the method further comprises storing the uniqueidentification code, which is electronically associated with each of theelectrode group leads, in physical association with each electrode grouplead, wherein the storing of the unique identification code in physicalassociation is achieved using any one of a crimp, an adhesive label oran embedded code on each electrode group lead.

Each connector of the plurality of connectors may further comprise avalue and wherein the value is representative of a number of permissibleuses of the connector of the plurality of connectors. The value may beindicative of a maximum number of sterilization cycles of the connectorof the plurality of connectors wherein the maximum number ofsterilization cycles is equal to, or less than, 20.

Optionally, the method further comprises, using the control unit,accessing a value associated with each connector of the plurality ofconnectors and limiting a number of times each connector of theplurality of connectors is used based on the value. The value may beindicative of a maximum number of sterilization cycles of the connectorof the plurality of connectors. The maximum number of sterilizationcycles may be equal to, or less than, 20.

The present specification also discloses a system for neuromonitoringand neurodiagnostics comprising: a plurality of electrode groups whereineach group comprises electrodes, each of said electrodes in each grouphaving at least one of a similar monitoring functionality type or asimilar deployment location and having at least one electrode grouplead; a plurality of connectors, wherein each electrode group lead ofsaid plurality of electrode groups is coupled to at least one connectorof said plurality of connectors, and wherein either each electrode grouplead of said plurality of electrode groups or each connector of saidplurality of connectors carries an associated unique identificationcode; and, a control unit comprising at least one receiving unitconfigured for receiving said plurality of connectors, establishing anidentity of each connector of said plurality of connectors byidentifying each unique identification code associated with eachconnector of said plurality of connectors or establishing an identity ofeach electrode group lead of said plurality of electrode group byidentifying each unique identification code associated with eachelectrode group lead of said plurality of electrode groups, andconfiguring the system to associate each electrode with a correspondinginput channel in the control unit based on said unique identificationcode.

Optionally, said unique identification code is in a 128 bit GUID format.

Optionally, said at least one receiving unit comprises a plurality ofinput sockets configured to receive one or more connectors of saidplurality of connectors. Optionally, said one or more connectors areconfigured to be coupled to any of the plurality of input sockets ofsaid at least one receiving unit.

Optionally, said connector has a designated output pin which isconfigured to transmit information related to the unique identificationcode to said control unit. Optionally, the information related to theunique identification code is formatted as a bar code or a radiofrequency code (RFID). Optionally, the information related to theidentification code is stored using multiple pins that are configured asdip switches comprising resistors.

Optionally, each of said plurality of connectors is configured to beinserted in said receiving unit using at least two differentorientations. Optionally, each of said plurality of connectors has twodesignated output pins which are configured to transmit informationrelated to the unique identification code and an orientation of theconnector to said control unit. Optionally, the two designated outputpins are maintained at different polarities or voltage levels toindicate the orientation of the connector as inserted in a receivingunit. Optionally, a physical position of said two designated output pinsis different in each of two orientations.

Optionally, said electrode group leads are coupled to inputs of the atleast one connector in a predefined order.

Optionally, said electrodes are configured in groups of 4, 6, 8, 10, 12or 16 electrodes.

Optionally, said system is configured to perform an EEG, PSG, EMG, orneuromonitoring procedure.

Optionally, said system is configured to perform an EKG procedure.

Optionally, the unique identification code associated with each saidelectrode group lead is positioned on each electrode group lead, andwherein the unique identification code is configured as any one of acrimp, an adhesive label or an embedded code on each electrode grouplead.

The present specification also discloses a medical system for monitoringof patient data comprising: a plurality of electrode groups configuredto be attached to a body of a patient wherein each electrode group insaid plurality of electrode groups comprises electrodes of a similartype having at least one of a similar monitoring functionality type or asimilar deployment location and having at least one electrode grouplead; a plurality of connectors wherein each connector includes a uniqueidentification code and wherein each electrode group lead of saidplurality of electrode groups is coupled to at least one connector ofsaid plurality of connectors; and, a control unit comprising at leastone receiving unit configured for receiving said plurality ofconnectors, establishing an identity of each of said plurality ofconnectors by identifying each unique identification code associatedwith each of said plurality of connectors, and configuring the system torelate each electrode with its corresponding input channel in thecontrol unit based on said identification code, wherein relate isdefined as placing the electrode in electrical communication with thecorresponding input channel.

Optionally, said medical system is configured to be used forneuromonitoring and neurodiagnostics applications. Optionally, theneuromonitoring and neurodiagnostics applications include EEG, EMG,IONM, and PSG.

Optionally, said medical system is configured to be used for an EKGprocedure.

Optionally, said unique identification code includes a counter to limitthe number of uses of the associated connector.

Optionally, said counter is indicative of a maximum number ofsterilization cycles of the associated connector, and wherein themaximum number is in a range of 5 to 20 sterilization cycles.

The present specification also discloses a medical system for monitoringof patient data comprising: a plurality of electrode groups configuredto be attached to a body of a patient wherein each electrode group insaid plurality of electrode groups comprises electrodes of a similartype having at least one of a similar monitoring functionality type or asimilar deployment location and having at least one electrode grouplead, wherein each electrode group lead includes a unique identificationcode; a plurality of connectors, wherein each electrode group lead ofsaid plurality of electrode groups is coupled to at least one connectorof said plurality of connectors; and, a control unit comprising at leastone receiving unit configured for receiving said plurality ofconnectors, establishing an identity of each of said electrode groupsidentifying each unique identification code associated with each of saidelectrode group leads, and configuring the system to relate eachelectrode with its corresponding input channel in the control unit basedon said identification code, wherein relate is defined as placing theelectrode in electrical communication with the corresponding inputchannel.

The present specification also discloses a system for neuromonitoringand neurodiagnostics comprising: a plurality of electrode groups whereineach group comprises electrodes, each of said electrodes in each grouphaving at least one of a similar monitoring functionality type and asimilar deployment location; a plurality of connectors wherein eachconnector comprises an electronically accessible memory and wherein aunique identification code is stored in each electronically accessiblememory and wherein each electrode group of said plurality of electrodegroups is coupled to at least one connector of said plurality ofconnectors; and, a control unit comprising at least one receiving unitconfigured for receiving said plurality of connectors, establishing anidentity of each connector of said plurality of connectors byidentifying each unique identification code associated with eachconnector of said plurality of connectors, and configuring the system toassociate each electrode with a corresponding input channel in thecontrol unit based on said unique identification code.

Optionally, said unique identification code is in a Global UniqueIdentifier (GUID) format, such as 128 bit.

Optionally, said at least one receiving unit comprises a plurality ofinput sockets configured to receive one or more connectors of saidplurality of connectors.

Optionally, said one or more connectors are configured to be coupled toany of the plurality of input sockets of said at least one receivingunit.

Optionally, said connector has a designated communication method whichis configured to transmit information related to the uniqueidentification code to said control unit.

Optionally, the information related to the unique identification code isformatted as a bar code or a radio frequency code (RFID).

Optionally, the information related to the unique identification code isstored in the electrode or electrode group and passed through thereceiving unit to the control unit.

Optionally, the information related to the identification code is storedusing multiple pins that are configured as dip switches comprisingresistors.

Optionally, each of said plurality of connectors is configured to beinserted in said receiving unit using at least two differentorientations.

Optionally, each of said plurality of connectors has two designatedoutput pins which are configured to transmit information related to theunique identification code and an orientation of the connector to saidcontrol unit.

Optionally, the two designated output pins are maintained at differentpolarities or voltage levels to indicate the orientation of theconnector as inserted in a receiving unit.

Optionally, a physical position of said two designated output pins isdifferent in each of two orientations.

Optionally, electrodes included in any one electrode group are coupledto inputs of the connector in a predefined order.

Optionally, said electrodes are configured in groups of 4, 6, 8, 10, 12or 16 electrodes.

Optionally, said system is configured to perform an EEG or EMGprocedure. Optionally, said system is configured to perform a PSG orneuromonitoring procedure.

The present specification also discloses a method for neuromonitoringand neurodiagnostics comprising: providing a plurality of electrodes fordeploying on different portions of a human body; arranging saidelectrodes in a plurality of electrode groups wherein each groupcomprises electrodes having at least one of a similar monitoringfunctionality type and a similar deployment location; coupling theelectrodes of each one of said plurality of electrode groups with oneconnector of a plurality of connectors, wherein each connector comprisesa unique identification code stored in an electronically accessiblememory in said connector; coupling each connector of said plurality ofconnectors with at least one receiving unit in communication with asystem control unit; establishing the identity of each connector of saidplurality of connectors from its unique identification code, whereinsaid receiving unit is configured to establish said identity byidentifying each unique identification code associated with eachconnector of said plurality of connectors; and, configuring the systemto associate each electrode with its corresponding input channel in saidcontrol unit based on said unique identification code.

Optionally, said unique identification code is in a GUID format, such as128 bit.

Optionally, said at least one receiving unit comprises input sockets inwhich one or more said connectors can be inserted.

Optionally, said connectors are connectors are configured to be coupledto any of the inputs of said at least one receiving unit.

Optionally, said connector has a designated communication method whichis configured to transmit information related to the uniqueidentification code to said control unit.

Optionally, the information related to identification code iscommunicated through a bar code or a radio frequency code (RFID).

Optionally, the information related to identification code iscommunicated from the electrode or electrode group through the receivingunit to the control unit.

Optionally, each of said plurality of connectors is configured to beinserted in said at least one receiving unit using at least twodifferent orientations, wherein said at least two different orientationscomprise at least a first orientation and at least a second orientation,wherein said second orientation is rotated 180 degrees about ahorizontal axis with respect to said at least first orientation.

Optionally, each of said plurality of connectors has two designatedoutput pins which are configured to transmit information related to theidentification code and an orientation of the connector to said controlunit.

Optionally, the two designated output pins are maintained at differentpolarities or voltage levels to indicate the orientation of theconnector as inserted in a receiving unit.

Optionally, a physical position of said two designated output pins isdifferent in each of said at least two orientations.

Optionally, electrodes included in any one of said group of electrodesare coupled to inputs of the connector in a predefined order.

Optionally, said electrodes are combined in groups of 4, 6, 8, 10, 12 or16 electrodes.

Optionally, said method may be used to perform an EEG or EMG procedure.Optionally, said method may be used to perform a PSG or neuromonitoringprocedure.

The present specification also discloses a medical system for monitoringof patient data comprising: a plurality of electrode groups configuredto be attached to a body of a patient wherein each electrode group insaid plurality of electrode groups comprises electrodes of a similartype having at least one of a similar monitoring functionality type anda similar deployment location; a plurality of connectors wherein eachconnector comprises an electronically accessible memory and wherein aunique identification code is stored in each electronically accessiblememory and wherein each electrode group of said plurality of electrodegroups is coupled to at least one connector of said plurality ofconnectors; and, a control unit comprising at least one receiving unitconfigured for receiving said plurality of connectors, establishing anidentity of each of said plurality of connectors by identifying eachunique identification code associated with each of said plurality ofconnectors, and configuring the system to relate each electrode with itscorresponding input channel in the control unit based on saididentification code, wherein relate is defined as placing the electrodein electrical communication with the corresponding input channel.

Optionally, said medical system is configured to be used forneuromonitoring and neurodiagnostics applications.

Optionally, said medical system is configured to be used for an EKGprocedure.

The aforementioned and other embodiments of the present specificationshall be described in greater depth in the drawings and detaileddescription provided below.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing and other objects and advantages will be apparent uponconsideration of the following detailed description, taken inconjunction with the accompanying drawings, in which like referencecharacters refer to like parts throughout.

FIG. 1 shows a block diagram of a conventional medical system comprisinga large number of electrodes deployed on a patient body;

FIG. 2 shows a block diagram of an illustrative medical systemcomprising a large number of electrodes deployed on the body of apatient as disclosed in accordance with an embodiment of the presentspecification;

FIG. 3A shows an exemplary connector and a receiving socket inaccordance with an embodiment of the present specification;

FIG. 3B shows an exemplary connector and a receiving socket inaccordance with another embodiment of the present specification;

FIG. 3C illustrates a prior art system for connection of at least oneelectrode (or at least one group of electrodes) to an amplifier of amedical device in an embodiment;

FIG. 3D illustrates a first embodiment of a system for connection of atleast one electrode (or at least one group of electrodes) to anamplifier of a medical device, in accordance with some embodiments ofthe present specification;

FIG. 3E is a flow chart showing steps in a method for using the firstembodiment of a system for connection of at least one electrode (or atleast one group of electrodes) to an amplifier of a medical device, inaccordance with some embodiments of the present specification and asshown in FIG. 3D;

FIG. 3F illustrates a second embodiment of a system for connection of atleast one electrode (or at least one group of electrodes) to anamplifier of a medical device, in accordance with some embodiments ofthe present specification;

FIG. 3G is a flow chart showing steps in a method for using the secondembodiment of a system for connection of at least one electrode (or atleast one group of electrodes) to an amplifier of a medical device, inaccordance with some embodiments of the present specification;

FIG. 4A shows an illustration of connectors of different sizes inaccordance with various embodiments of the present specification;

FIG. 4B illustrates a first consolidator for receiving a plurality ofconnectors, in accordance with some embodiments of the presentspecification;

FIG. 4C illustrates a second consolidator for receiving a plurality ofconnectors, in accordance with some embodiments of the presentspecification;

FIG. 4D illustrates the electrical connections of the consolidator shownin FIG. 4C housed in a bracket for data communication with a third partydevice, in accordance with some embodiments of the presentspecification;

FIG. 5A shows an exemplary illustration of an eight channel connectordeployed to support an eight input depth electrode in an EEG procedurein accordance with an embodiment of the present specification;

FIG. 5B shows a detailed illustration of the eight channel connectordeployed to support an eight input depth electrode in an EEG procedureas depicted in FIG. 5A;

FIG. 6 shows a 64 electrode grid deployed on the brain using connectorsin accordance with an embodiment of the present specification;

FIG. 7 shows a flowchart illustrating the steps performed in a method ofconfiguring an electrode connection system in accordance with oneembodiment of the present specification;

FIG. 8A shows a control unit of a 256 channel neuromonitoring andneurodiagnostics EEG system having receiving sockets which areconfigured to receive multiple connectors, in accordance with anembodiment of the present specification;

FIG. 8B shows the system of FIG. 8A being used for monitoring theneurological state a patient;

FIG. 9A shows an illustration of an exemplary connector and receivingsocket in accordance with various embodiments of the presentspecification;

FIG. 9B shows another illustration of an exemplary connector andreceiving socket in accordance with other embodiments of the presentspecification;

FIG. 10 illustrates a connector which can be used in dual orientationsin accordance with an embodiment of the present specification; and

FIG. 11 illustrates a connector which can be used in dual orientationsin accordance with another embodiment of the present specification.

DETAILED DESCRIPTION

The system, devices, and methods described below disclose a novelelectrode management solution for neuromonitoring and neurodiagnosticsapplications such as electroencephalography (EEG) procedures. Systemsand methods are disclosed which provide a highly reliable and convenientmethod for electrode management in such applications. In embodiments ofthe disclosed system, the physician is not required to manually matcheach electrode lead with its corresponding input channel on the systemcontrol unit, significantly reducing the set up time and reducingerrors. The electrodes are not directly connected with the inputchannels in the control unit or the amplifier of the neuromonitoring andneurodiagnostics system. Rather, the control unit is coupled toelectrodes or groups of electrodes with the help of unique connectorsand corresponding receiving sockets which enable automatic detection ofthe electrodes, including their type and deployment location. Once theelectrodes are identified, the control unit reconfigures the system toautomatically correlate, associate, assign, or ‘map’, each electrodewith its corresponding input channel in the control unit, whereincorrelate, associate, assign, relate, or map is defined as placing aspecific electrode in electrical communication with the correspondingspecific input channel in the control unit. The connectors and receivingsockets ensure the control unit will recognize each electrode properlyand process information received from each electrode correctly withrespect to the electrodes placement position on the patient's body,regardless of where the connector is inserted into the receiving socket.

In embodiments, the electrodes are arranged into a plurality of groupssuch that the electrodes of similar type, based on their similarmonitoring functionality and similar deployment location on a humanbody, are included in the same group. Multiple electrodes become easierto manage when they are grouped for connection to the connectors (ormass termination blocks) of the present specification. Thus, grouping ofmultiple electrodes facilitates management. For purposes of the presentspecification, the term “similar monitoring functionality” shall meanelectrodes that are used for similar neuromonitoring andneurodiagnostics modalities. For example, electrodes used for studiesincluding, but not limited to, electroencephalography (EEG),electromyography (EMG), polysomnography (PSG), intraoperative neuralmonitoring (IONM) and evoked potentials are gathered into groups ofsimilar monitoring functionality. Accordingly, all electrodes being usedfor an EEG constitute electrodes having a similar monitoringfunctionality and are expressly differentiated from (and therefore donot have similar monitoring functionality as) those electrodes beingused for other modalities, such as an EMG. For purposes of the presentspecification, the term “similar deployment location” shall meanelectrodes that are positioned together in a specific area on apatient's head, scalp, or brain. For example, electrodes configured tobe placed on a front, back, left side, or right side of a patient'sscalp or brain would be gathered into groups of similar deploymentlocation based on each area. Accordingly, all electrodes being deployedin front side of a patient's scalp or brain constitute electrodes havinga similar deployment location and are expressly differentiated from (andtherefore do not have a similar deployment location as) those electrodesbeing deployed on the back side, left side, or right side of thepatient's scalp, each of those being different deployment locations.

Subsequently, each group of electrodes is mapped to a separate connectorin a pre-defined order and all such connectors are coupled with areceiving socket on the system control unit. When a group of electrodesare mapped to a connector, the exact position and type of each electrodein that group is standardized, as the electrodes are coupled to aconnecter in a pre-defined order, and the connector is assigned a uniqueidentification code or ID. As an alternate embodiment, the uniqueidentification code may be transmitted from the electrode or group ofelectrodes through the connectors to the receiving sockets in thecontrol unit. The connectors and the receiving sockets have an identity(ID) read capability such that when any connector is inserted in thereceiving socket, the receiving socket can identify the connector fromits unique identification code or ID and based on the identity of theconnector, the specific location and type of all the electrodes mappedto this connector are established. The ID information is carriedexplicitly by the connector (or the electrode or group of electrodes andtransmitted by the connector), and not implicitly by the receptacle. TheID information is stored in electronically accessible memory on theconnector, electrode, or group of electrodes. In various embodiments,the memory is any one or combination of non-volatile memory, such asread-only memory (ROM), programmable read-only memory (PROM), erasableprogrammable read-only memory (EPROM), and electronically erasableprogrammable read-only memory (EEPROM), and volatile memory, such asdynamic random-access memory (DRAM) and static random-access memory(SRAM). Alternatively, the ID information may be stored in RFID,barcode, or other non-volatile format. The electrodes of a group and theconnector are never separated, and if the connector is reinsertedelsewhere on an array of available inputs, the system will remap theinputs to the correct channels. Therefore, the system allows for theunplugging of a connector from a physical port and subsequent relocationof the connector to a different physical port, even a physical port on adifferent amplifier, while retaining the logical mapping of eachelectrode. Automatic mapping of electrodes as connectors are removed andplaced in a different location ensures data associated with eachelectrode is correctly reported. The ID information is for allelectrodes in a group, which, in some embodiments, is at least 16 at atime, compared to one electrode at a time which is encountered incurrent systems. The information needed to determine where the electrodeis attached is a function of at least one or more of the connector,electrode, or electrode group (using its unique ID) and either apre-defined setup (for example, in the case of a 10/20 system headcap)or a setup specified on a per connector basis by the user to a computersystem.

In embodiments, when a connector is coupled with a receiving socket, themedical system requests for the information on the electrodes coupled toeach input of that connector. The user subsequently provides informationon the various electrodes coupled to the specific inputs of theconnector. In an embodiment, the user manually inserts this information(or selects the data from a list of available options) through anelectronic keyboard or keypad coupled with the medical system. Once theuser provides this information, the exact position and type of eachelectrode in a group coupled with a specific connector is standardized.In some alternate embodiments, the standardized information related toexact order in which electrodes are coupled to each connector isprovided to the medical system before inserting the connectors in thereceiving socket. In another alternate embodiment, information about theelectrode or electrode group, such as a unique ID, number of electrodes,size, or shape is contained in the ID stream coming directly from theelectrode or electrode group.

The receiving socket comprises a bank of input points and is configuredsuch that various connectors having unique IDs and representing separategroups of electrodes can be inserted in any of the inputs on thereceiving socket. Once the receiving socket establishes an electricalconnection with a connector, it can read the unique ID of the connectorto establish its identity. On establishing the identity of theconnector, the system is able to recognize the type and specificlocation of various electrodes mapped to the connector.

Using the concept of connectors with unique ID as disclosed herein, theposition of the electrodes in a specific group is standardized withrespect to the connector. The electrodes from the same group are coupledto inputs of the connector in a pre-defined sequence and the systemreading the unique ID of the connector assigns the correct meaning(electrode type and location) to each input. In embodiments, the systemincludes a pre-defined list of available electrodes (catalog items thatare available from manufacturers) and the medical care provider needs toensure that the correct electrode(s) corresponding to a single connecterare mapped to each unique ID of the connector. For example, if anelectrode has multiple leads, such as four leads with 16 electricalcontacts each (which is the case with a 64-lead grid electrode in an 8×8array), then the care provider needs to ensure that each of the fourleads (1-4) for the 8×8 grid electrode are properly mapped to thecorrect connector. Thus, a total of four logical mappings reside in thesoftware application, versus the need to plug 64 color coded connectorsinto the correct amplifier channel number. Once identified, theelectrode groups can be removed and reinserted in any available slot inthe system, for example, to other slots within the same amplifier, toanother amplifier, or to a new amplifier (replacing an amplifieraltogether), without error. The system will note the new connection andassign the correct meaning to the input. Handling electrode leads insmall groups makes the entire set up process less cumbersome in case ofhigh density electrode applications, such as EEG procedures involving alarge number of electrodes, for example greater than 64 or even morethan 500. In conventional systems, if the electrical connectorscorresponding to electrodes are removed and reinserted into receptacleslocated within the medical device, each electrical connector has to bereinserted into exactly the same receptacle or the electrode body siteto channel display will be incorrect. However, in the above disclosedsystem, the user can remove the various connectors from the medicaldevice and can reinsert these connectors in any of the input points inthe receiving sockets.

In some embodiments, the systems and methods of the presentspecification also provide reverse identification of electrodes and/orconnectors from a software application. Once standardized informationrelating to an electrode or connector is established as described in thepresent specification (for example, via a unique ID of a connector), auser may select a graphical representation of an electrode or connector(for example, a signal trace displayed on a user interface) to identifythe specific physical electrode or connector associated therewith. Insome embodiments, electrodes (and/or leads of the electrodes) andconnectors of the present specification include lights which illuminatein response to specific actions by a user. In one embodiment, a user mayclick on a trace displayed on a graphical user interface (GUI) of thesystem which triggers a connector visual indicator, such as a light(positioned proximate to or on) a connector to illuminate, providingvisual identification of the corresponding connector to the user. Inanother embodiment, a user may click on a trace displayed on GUI of thesystem which triggers an electrode visual indicator, such as a light(positioned proximate to or on) an electrode (for example, an electrodepositioned on a patient's scalp) to illuminate, providing visualidentification of the corresponding electrode to the user. In yetanother embodiment, a user may click on a trace displayed on GUI of thesystem which triggers a lead visual indicator, such as a light(positioned proximate to or on) a lead attached to an electrode (forexample, a lead attached to an electrode positioned in a patient'sbrain) to illuminate, providing visual identification of where thecorresponding electrode enters a patient's skull.

An exemplary beneficial use of the connector systems of the presentspecification is with an MRI procedure. During an MRI, the monitoringsystem amplifier inputs need to be disconnected from the amplifieritself as the amplifier is not allowed into the intense magnetic fieldsgenerated by the MRI machine. Disconnecting and reconnecting 200 leadsfor such a procedure is time consuming and error prone. Such a laboriousprocess can preclude the use of an MRI procedure, even if it is thepreferred imaging technique. If an amplifier fails, the leads would needto be moved. In a set of 200 non-identified individual leads, theprocess is not only error prone, but each channel would have to beremapped manually, and in some systems, the channels have to be usedconsecutively, so the ‘abandoned’ channels continue to be displayed. Inthe identified connector systems of the present specification, there isless chance for error in reconnecting the leads and the process is muchquicker.

A “computing device” refers to at least one of a cellular phone, PDA,smart phone, tablet computing device, patient monitor, custom kiosk, orother computing device capable of executing programmatic instructions.It should further be appreciated that each device and monitoring systemmay have wireless and wired receivers and transmitters capable ofsending and transmitting data. Each “computing device” may be coupled toat least one display, which displays information about the patientparameters and the functioning of the system, by means of a GUI. The GUIalso presents various menus that allow users to configure settingsaccording to their requirements. The system further comprises at leastone processor to control the operation of the entire system and itscomponents. It should further be appreciated that the at least oneprocessor is capable of processing programmatic instructions, has amemory capable of storing programmatic instructions, and employssoftware comprised of a plurality of programmatic instructions forperforming the processes described herein. In one embodiment, the atleast one processor is a computing device capable of receiving,executing, and transmitting a plurality of programmatic instructionsstored on a volatile or non-volatile computer readable medium. Inaddition, the software comprised of a plurality of programmaticinstructions for performing the processes described herein may beimplemented by a computer processor capable of processing programmaticinstructions and a memory capable of storing programmatic instructions.

“Electrode” refers to a conductor used to establish electrical contactwith a nonmetallic part of a circuit. EEG electrodes are small metaldiscs usually made of stainless steel, tin, gold or silver covered witha silver chloride coating. They are typically placed on the scalp onpredetermined locations.

A “subdural electrode grid” refers to a thin sheet of material withmultiple small (roughly a couple mm in size) recording electrodesimplanted within it. These are placed directly on the surface of thebrain and have the advantage of recording the EEG without theinterference of the skin, fat tissue, muscle, and bone that may limitscalp EEG. Shapes and sizes of these sheets are chosen to best conformto the surface of the brain and the area of interest.

A “depth electrode” refers to small wires that are implanted within thebrain itself. Each wire has electrodes which surround it. Theseelectrodes are able to record brain activity along the entire length ofthe implanted wire. They have the advantage of recording activity fromstructures deeper in the brain. They can be implanted through small skinpokes.

The present specification is directed towards multiple embodiments. Thefollowing disclosure is provided in order to enable a person havingordinary skill in the art to practice the invention. Language used inthis specification should not be interpreted as a general disavowal ofany one specific embodiment or used to limit the claims beyond themeaning of the terms used therein. The general principles defined hereinmay be applied to other embodiments and applications without departingfrom the spirit and scope of the invention. Also, the terminology andphraseology used is for the purpose of describing exemplary embodimentsand should not be considered limiting. Thus, the present invention is tobe accorded the widest scope encompassing numerous alternatives,modifications and equivalents consistent with the principles andfeatures disclosed. For purpose of clarity, details relating totechnical material that is known in the technical fields related to theinvention have not been described in detail so as not to unnecessarilyobscure the present invention.

In the description and claims of the application, each of the words“comprise” “include” and “have”, and forms thereof, are not necessarilylimited to members in a list with which the words may be associated. Itshould be noted herein that any feature or component described inassociation with a specific embodiment may be used and implemented withany other embodiment unless clearly indicated otherwise.

FIG. 1 show a block diagram of a conventional medical system 100comprising a large number of electrodes deployed on a patient 102 body.The medical device 101 represents any conventional neuromonitoring andneurodiagnostics medical system which comprises a large number ofelectrodes, such as an EEG (electroencephalography) system, which isused for monitoring the neurological state of a patient for diagnosisand preventive treatment of certain diseases and for monitoring patientsduring anesthesia, among other procedures. As shown in FIG. 1, themedical device 101 is coupled to the patient 102 through a plurality ofelectrical leads 103 such that each of the leads 103 is coupled to anelectrode (not shown) positioned at an appropriate location on the bodyof the patient. In applications that require a large number ofelectrodes to be coupled to the human body, the setup, placement andmanagement of electrodes is a cumbersome process. As each electrode ispositioned at a different location to capture the electrical activity inits vicinity, the input recorded from each electrode has to be processedindependently. Therefore, the system is required to recognize theidentity of each of the electrical leads 103 and accordingly process theinput received from it. After positioning any electrode at its requiredlocation on the body of the patient 102, the user is required tocorrectly insert the electrode lead 103 corresponding to each electrodein a specific input channel configured for that electrode in the medicaldevice 101. In case the number of electrodes is small, for example, lessthan ten or fifteen, it is possible for the user to identify and connectelectrodes with the correct input channels. However, as the number ofelectrodes increases, this process become very difficult and is prone toerror. Further, even if the electrodes are coupled to the correct inputslots in the medical device 101, it is practically very difficult andtime consuming to recheck and verify the integrity of each connectionbefore every procedure. Usually, in such high density configurations,the set up process is so time consuming that in some circumstances, forexample during a surgical procedure, the user completely or partiallyskips the step of checking each connection for integrity until after thesurgery is finished, which increases the possibility of error in theprocedure.

FIG. 2 shows a block diagram of an illustrative medical system 200comprising a large number of electrodes deployed on the body of apatient 202 as disclosed in an embodiment. The medical device 201comprises a number of electrodes (not shown) coupled to the body of thepatient 202 through a plurality of electrical leads 203. Inneuromonitoring and neurodiagnostics medical procedures such as EEG, theelectrodes come in groups such that the electrodes in a specific grouphave similarities in terms of their input signal and positioning. In thesystems and methods described herein, the electrodes and thecorresponding electrical leads 203 are also arranged in a plurality ofgroups such as 203 a, 203 b, . . . , 203 n such that each of thesegroups comprises electrodes of similar type and location and isconfigured independently. In the disclosed arrangement, instead ofdirectly connecting the medical device 201 with the deployed electrodes,the electrodes are arranged in groups and each group is coupled to themedical device 201 through a connector 205 having a unique ID. Each ofthe groups of electrical leads 203 a, 203 b, . . . , 203 n (representingelectrodes of similar type and location) is coupled to a correspondingconnector 205 a, 205 b, . . . , 205 n such that the group of electricalleads 203 a is coupled to the connector 205 a, the group of electricalleads 203 b is coupled to the connector 205 b, and similarly the groupof electrical leads 203 n is coupled to the connector 205 n. The variousconnectors 205 a, 205 b . . . , 205 n are connected with a receivingsocket 204 which is coupled to the medical device 201. The receivingsocket 204 comprises a bank of inputs and is configured to receive theconnectors 205 a, 205 b, . . . , 205 n in any of these inputs. Each ofthe connectors 205 a, 205 b, . . . , 205 n has an independent identityand the receiving socket 204 is configured to establish the identity ofany such connector when the same is connected with it. By establishingthe identity of any connector 205, the system 200 is able to identifythe various electrodes, including their type and location, coupled toeach connector 205. All the electrodes coupled to a single connector 205belong to the same group and are hence interchangeable in terms of theirsignal conditioning requirements. The anatomic positions of the patientconnected electrodes coupled to the corresponding electrical leads 203are always in the same defined input sequence on connector 205. Further,as the receiving socket 204 is configured to identify any connector 205from its unique ID and, therefore, the group of electrodes coupled tothat connector 205, the connectors can be plugged into any of the inputsin receiving socket 204.

In an embodiment, the connectors 205 a, 205 b, . . . , 205 n comprise adesignated pre-defined identification output point/pin such that, whenany connector is plugged into the receiving socket 204, the receivingsocket 204 reads the information received from the output pin toestablish the identity of the connector 205. Once the identity of aconnector 205 is established, the system 200 recognizes the set ofelectrodes mapped with that connector 205 and reconfigures itself toautomatically correlate, associate or map each electrode with itscorresponding input channel.

Using the concept of handling electrodes in independent groups asdescribed above, instead of manually mapping each electrode with itscorresponding input channel in the medical device 201, the user onlyneeds to ensure that the electrodes belonging to the same group arecoupled to the same connector in the same order. This occurs by defaultwhen the inputs are part of a mechanically defined grid or strip.Subsequently, the user can insert multiple such connectors in areceiving socket in any of its inputs. The disclosed methodsignificantly reduces the set up time required before starting anymedical procedure as the conventional process of manually mappingelectrodes with input channels is very tedious and time consuming.Disclosed systems and methods also reduce the risk of error by obviatingthe human involvement in mapping of electrodes with corresponding inputchannels.

The number of electrodes coupled to any of the connectors 205 can varyand is dependent on the actual medical requirement. Usually, theelectrodes which are deployed in the similar location and receivesimilar input signal can only be grouped and coupled to a singleconnector. In medical procedures such as an EEG, the electrodes come ingroups of 4, 5, 6, 8, 10 and 16 electrodes, wherein each such group istargeted towards a specific part of the brain. In such cases, multipledifferent sized connectors are deployed which are capable of supportingthe above mentioned groups of electrodes.

FIG. 3A shows an exemplary connector 300 and a receiving socket 310 inan embodiment. As shown in FIG. 3A, the connector 300 comprises aplurality of signal output pins 302 which corresponds to a plurality ofelectrodes (not shown) deployed on the body of the patient with the helpof the connector 300. The connector 300 is coupled to the plurality ofelectrodes through one or more electrical leads (not shown). In someembodiments, the connector 300 is coupled to the electrodes through awireless communication link. In embodiments, each connector, such as theconnector 300, has a unique identity and is coupled to a plurality ofelectrodes which are included in the same group. In some embodiments,wired (via electrical leads) and/or wireless connections transmit theunique identity (such as GUID) and information about the electrodes, aswell as signal data from the electrodes, to the system. In someembodiments, wherein the connection is wireless, transmission isdirectly from the wireless electrode to the system. In otherembodiments, wherein the connection is wireless, transmission is from awireless connector attached to each electrode and configured tobroadcast information, including but not limited to, signal data andGUID, from the electrode to the system. When the electrodes areclassified in the same group, it means their input signals are of thesame type and their relative positions are fully defined. Theseelectrodes are connected to the input terminals of the connector in aspecific pre-defined order. FIG. 3A shows an ‘n’ channel connector 300,which means that the connector 300 can accommodate an electrode groupwith maximum number of n electrodes wherein n is any natural number. Incommercial applications, the value of n is usually 4, 6, 8, 10, 12 and16, such that the corresponding number of electrodes can be coupled to asingle connector.

In an embodiment, the connector 300 comprises a specific identification(ID) output pin 301 which is used to establish the unique identity (ID)of the connector 300. The receiving socket 310 comprises a bank ofsignal input points or sockets 311 which are configured to receive thesignal output pins 302 of the connector 300. Usually, a receivingsocket, such as the receiving socket 310, comprises enough input pointsto receive multiple connectors. In practical applications involving highdensity electrodes, the number of input points is over 200. Thereceiving socket 310 is coupled to a control unit/amplifier (not shown)which is used to control the entire system. In an embodiment, thereceiving socket 310 comprises a separate ID input socket 312 which isconfigured to receive the ID output pin 301 of the connector 300. Theconnector 300 is inserted in the receiving socket 310 such that the IDoutput pin 301 is received in the ID input socket 312 and the signaloutput pins 302 are received in a subset of signal input sockets 311.Referring to FIG. 3A, in some embodiments, the system includes aplurality of receiving sockets 310 and a plurality of connectors 300wherein any connector 300 can be inserted into any receiving socket 310such that the ID output pin 301 aligns with and inserts into acorresponding ID input socket 312.

Once the identity of the connector 300 is established, the system isable to identify the type and location of all the electrodes coupled tothe connector 300 irrespective of the set of input sockets 311 in whichthe connector 300 is inserted. Once the electrodes are identified, thecontrol unit coupled to the receiving socket 310 reconfigures the systemto automatically correlate, associate, assign or map each electrode withits corresponding input channel.

Each of the connectors, such as the connector 300, has a unique ID(identity). This identification information is stored in the connector300 and is accessible to the system from its identification (ID) outputpin 301. The ID information specifies the type and relative location ofeach electrode in the connector 300. In embodiments, the ID fieldcomprises a GUID (Globally Unique Identifier) which is a standard formatcomprising 128-bit data and is used as an identifier in the computersoftware. It may also contain other device specific information aboutthe attached device. In some embodiments, the unique ID comprisesradio-frequency identification (RFID), near-field communication (NFC),integrated circuit (IC) chip, barcode, quick response (QR) code, oroptical encoding. In some embodiments, the unique ID comprises GlobalUnique Device Identification Database (GUDID) information, Global TradeItem Number (GTIN) information, or a universally unique identifier(UUID). In some embodiments, connectors are identified by mechanicallockout (unique connectors for a quantity of electrodes) or colorcoding. Once a GUID is assigned, each input can be uniquely identifiedthereafter. In embodiments, the GUID data is stored in an inbuilt memorydevice in the connector 300 and, optionally, the memory device is anEPROM storage device. In some embodiments, the GUID is a digital IDwhich stores additional metadata with the electrode such as checksums,productions dates and authenticity. In other embodiments, the sameelectrode information is stored using multiple pins used like dipswitches (combinations=2^(n), i.e. 3 connections would give 8combinations), with a resistor whose value represents the input type(i.e. 10 combinations per resistor), with a multiple pin multipleresistor (100 combinations with 2 pins), or with a bar code that couldbe read automatically. In other embodiments, the identificationinformation is communicated through an RFID stored in the connector.

In some embodiments, the unique ID (for example, GUID) of each connectoris ‘system-wide’ across all medical device modalities or allneurological medical device modalities. In some embodiments, the uniqueID is specific not only to EEG devices but also to at leastintraoperative monitoring (IOM), sleep, and electromyography (EMG)devices. For example, in one embodiment, unplugging an implanted gridelectrode connector from an EEG amplifier and plugging it into an IOMmachine would result in the GUID from the electrode connector being usedby the IOM machine to access all data and configuration settings for theelectrode from the system and applying the data as appropriate to theacquisition, analysis, and display within the new modality.

Further, in some embodiments, each unique ID is associated with a value,such as a counter, that is stored in a memory accessible to the controlunit and usable by the control unit to limit the number of uses of theconnector. The number of uses of a connector are tallied in relation tothe counter and saved by the system as data associated with theconnector. In some embodiments, the controller unit uses the counterdata to count the number of total lifetime uses to prevent the use of apotentially worn out connector or a connector that has reached themaximum number of sterilization cycles. In some embodiments, the maximumnumber of sterilization cycles is in a range of 5-20. In someembodiments, the maximum number of mechanical connections before aconnector becomes worn out is in a range of hundreds to thousands ofconnections, depending on the type of connector being used. In someembodiments, the counter date is used to track the number of licenseduses of the connector. For example, in an embodiment, a customerpurchases the use of a connector on five patients. The counter tracksthe five patients and then the system disables the connector for use onfurther patients beyond the first five until additional licenses arepurchased, or determines how much a customer should be charged for theusage. In some embodiments, the counter tracks the number of uses of aconnector between preventative maintenance checks. In some embodiments,the counter tracks a total number of sterilization cycles.

In some embodiments, data stored and associated with each unique IDincludes but is not limited to the information listed below such thatall aspects of a system, patient, and procedure data related to aconnector (and associated electrode(s)) are retained when a connectionof the connector is changed (physically moved):

-   -   Patient association (which patient an electrode is connected to)    -   Display settings (how data from the associated patient is being        displayed)    -   Configurations settings (how data from the associated patient is        filtered, analyzed, referenced, and montaged prior to display)        as elements that are associated with the unique ID    -   Specific electrode make and model (part number, lot number,        serial number, and manufacturer) and region (for example, lower        left quadrant of a 64 electrode grid)    -   Electrode characteristics and limitations (for example, ‘do not        stimulate with this electrode’, maximum current, and number of        common references)    -   Electrode history, such as impedance history and failure history

In the embodiment shown in FIG. 3A, the connector 300 is shown as a maleelectrical connector and the corresponding receiving socket 310 is shownas a female electrical connector. In other embodiments, the connector isconfigured as a female connector and the receiving socket is configuredas a male connector.

In another embodiment shown in FIG. 3B, the connector 320 is configuredsuch that the ID output pin 321 is aligned parallel to, but not inseries with, the set of signal output pins 322. The correspondingreceiving socket 330 is configured such that instead of only one IDinput socket, the receiving socket 330 comprises a plurality of ID inputsockets 333 which are aligned parallel to the set of signal inputsockets 331. The connector 320 and the receiving socket 330 shown inFIG. 3B are configured such that the connector 320 can be inserted inany of the input sockets 331 provided the ID output pin 321 is receivedby at least one of the ID input sockets 333.

The connectors and receiving sockets of the present specification areconfigured such that connections between the two are secure andreliable. In some embodiments, the connection between the connectors andreceiving sockets is magnetically coupled. In some embodiments, theconnection between the connectors and receiving sockets is directionindependent such that the connectors are reversible about a horizontalplane. In some embodiments, the receiving sockets are configured to havesufficient depth such that inserted connectors cannot be removed bypulling on an attached cable sideways but only by pulling the connectorstraight out. With magnetic connectors, incorporating depth to thereceiving sockets to restrict removal of the connector to only straightout maximizes the magnetic strength and keeps the connector connectedunless a certain amount of force is used. The depth incorporated in thesockets depends on the geometry of the connector and varies by socket.In some embodiments, the receiving socket produces an audible ‘click’when the connector is fully inserted to provide confidence that theconnector is properly connected to the receiving socket. In addition, invarious embodiments, all components of the systems of the presentspecification, including the connectors and receiving sockets, aredesigned mechanically to meet isolation and standoff requirements forshock hazard.

In some embodiments, not all of the available electrode channels on aconnector might be used. For example, a 16 channel GUID connector mightbe used with a 10 channel electrode connected to it. In these instanced,the systems of the present specification provide for auto disabling ofunused channels for standard electrodes and modified electrodes which donot display or store data. The systems will automatically detectdisconnected channels or will, by reference from the configuration ofthe attached electrode either through direct association by the user orfrom information obtained directly from the ID of the electrode, knowwhich connector channels are not physically connected to an electrodeand will ‘turn off’ acquisition and display of the unused channels.

As discussed above, in some embodiments the connectors are associatedwith a GUID since. In prior art systems, electrodes are typically “offthe shelf” and are associated with a color-coded identification fordifferentiating the placement of each electrode on the surface (or in adepth) of a patient's brain. However, such “off the shelf” color-codedelectrodes do not have any machine-readable globally unique ID and areunique only to a case or patient.

FIG. 3C illustrates a prior art system 300 c of connecting at least oneelectrode (or at least one group of electrodes) to an amplifier of amedical device in an embodiment. As shown, a 4-element strip electrode332 and an 8×8 element grid electrode 334 are positioned within apatient's brain 335. In embodiments, in order to position on a patient'sscalp (extracranial), a cap may be used. The electrode lead 336 from the4-element strip electrode 332 is configured to be inserted into anadapter connector 338, which is configured for receiving electrode 332.The electrode lead 336 has a color-coded band or anumerical/alpha-numerical code 337 that uniquely identifies theelectrode 332 for that particular patient but that is not globallyunique (that is, each code is to be used only once). An adapter cable340, emanating from the adapter connector 338, terminates into aplurality of “touch proof” connectors 342 that need to be manuallymapped into appropriate jacks 344 on the amplifier 346. Thus, manualintervention is required.

During surgery, the strip electrode 332 is placed on the surface of thebrain 335, the location of the strip electrode 332 is documented, andthe color code or numerical/alpha-numerical code 337 associated witheach electrode is recorded. In other words, in a cumbersome manualprocess, the user must read the color bands or codes 337, associatethose colors or codes with the type of electrode the color bands orcodes represent, and the location of the electrode on the brain (from asurgical case documentation). This is done while the brain is exposedvia a craniotomy. After the surgery is complete, the craniotomy site isclosed and the user can no longer see the electrodes, only the“pigtails” or the electrode lead 336 with color coded bands or codes 337which indicate the nature and location of the electrode. In addition,when connectors 342 are removed from the amplifier 346 they must bemanually remapped upon re-insertion. This procedure is slow and prone toerrors. Mapping errors can lead to improper diagnosis and possibly anincorrect treatment including removal of the wrong portion of the brainduring a surgical procedure.

FIG. 3D illustrates a first system 300 d for connecting at least oneelectrode (or at least one group of electrodes) to an amplifier of amedical device, in accordance with some embodiments of the presentspecification. As shown, a 4-element strip electrode 332 and an 8×8element grid electrode 334 are positioned on the surface of thepatient's brain 335. In embodiments, in order to position on a patient'sscalp (extracranial), a cap may be used. The electrode lead 336emanating from the 4-element strip electrode 332 is configured to beinserted into the adapter connector 338 for electrical connection. Theelectrode lead 336 has a color coded band or a numerical/alpha-numericalcode 337 that uniquely identifies the electrode 332 for the particularpatient but that is not globally unique (that is, each code is to beused only once). An adapter cable 340, emanating from and in electricaland/or data communication with the adapter connector 338, terminates andis in electrical and/or data communication with a connector 350 thatincludes a GUID tag in accordance with some embodiments of the presentspecification. The connector 350 is inserted into any of the appropriatesockets 352 on the amplifier 354. In embodiments, sockets 352 areuniversal sockets. In embodiments, connectors 350 may vary in size suchthat one connector 350 may fit into a plurality of sockets 352. Forexample, a connector 350 may, in embodiments, be twice the originalwidth and therefore may be received by two sockets 352.

In accordance with an aspect, the amplifier 354 includes a reader (notshown) to detect the GUID tag in the connector 350 and acquire aplurality of information stored in the GUID tag. Once the connector 350is inserted into one of the sockets 352, the system 300 d recognizesthat a new connector 350 has been connected to the amplifier 354 and theuser is prompted to identify what was connected. Thus, if anunrecognized GUID is inserted into a socket 352, the system, via theGUI, prompts the user to identify the electrode that was connected. Theuser accesses at least one GUI (Graphical User Interface) that enablesthe operator to select from a plurality of pre-programmed electrodetypes (or enter customized types). Specifically, in an embodiment, theuser may select from a drop-down list of possible electrodes. In oneembodiment, the drop-list prompts the user to identify the electrodes bymanufacturer part number. In some embodiments, electrodes may havemultiple leads as is shown by grid electrode 334. In such cases, theuser will need to identify both the correct manufacturer part number andthe correct lead number (for example, 1-4). The GUI also provides aunique and simple interface to associate a color code or alphanumeric IDto the electrode for reference.

U.S. patent application Ser. No. 16/697,850, entitled “Methods forAutomatic Generation of EEG Montages” and filed on Nov. 27, 2019, alsoby the Applicant of the present specification, is herein incorporated byreference in its entirety. Once an association has been made between theunique ID in the connector 350 and electrode 332, the connector 350 maybe moved to a different socket 352 on the amplifier 354 or even to adifferent amplifier altogether and the system 300 d will still “know”(as the information is stored in the system) what is connected and howto map the data appropriately within the software application of themedical device. Thus, once the identity of the connector 350 isestablished, the system is able to identify the type and location of allthe electrodes (or group of electrodes) coupled to the connector 350irrespective of the set of input sockets 352 in which the connector 350is inserted. In embodiments, adapter connector 338 and adapter cable 340which emanates from and is in electrical and/or data communication withthe adapter connector 338 and which terminates and is in electricaland/or data communication with a connector 350 are reusable. It shouldbe noted that once mapping information is erased, the assembly, whichinclude adapter connector 338, adapter cable 340, and connector 350 maybe sterilized and a new mapping may be created for the same GUID on thenext patient. Thus, if the electrode lead 336 is removed from theadapter connector 338, then the user will need to re-map which electrodeis connected to the adapter connector when re-connected once mappinginformation is intentionally deleted. If the electrode lead 336 isremoved from the adapter connector 338, and then re-inserted into thesame adapter connector 338, the mapping will remain in the systemmemory.

FIG. 3E is a flow chart showing steps in a method for using the firstembodiment of a system for connection of at least one electrode (or atleast one group of electrodes) to an amplifier of a medical device, inaccordance with some embodiments of the present specification and asshown in FIG. 3D. At step 370, a 4-element strip electrode and/or an 8×8element grid electrode are positioned on or within the patient's brain.The electrode lead emanating from the 4-element strip electrode isinserted into the adapter connector for electrical connection at step372. A connector, which is in electrical and/or data communication withthe adapter connector via an adapter cable is inserted, at step 374,into an appropriate socket on an amplifier. Once the connector isinserted into one of the sockets, the system recognizes that a newconnector has been connected to the amplifier and the user is promptedto identify what was connected, in step 376.

In various embodiments, the connector 350 is magnetically coupled withthe sockets 352. In various embodiments, the connection between theconnector 350 and receiving sockets 352 is direction independent suchthat the connectors are reversible about a horizontal plane. Inembodiments, the connector 350 may vary in size to optimally match thenumber of leads on the electrode. In embodiments, there may be unusedpins of receiving sockets 352 depending on which electrode is connected.In embodiments, pins on connector 350 may be used to transmit GUID data.

In some embodiments, a pigtail ID tag or pigtail GUID tag is added to alead of an electrode to provide means of identifying and storinginformation related to the electrode. In other embodiments, an ID tag isassociated to an electrode by other connection means, such as a wirelessRF (Radio Frequency) or an optical connection. In various embodiments,the pigtail ID tag is applied to the electrode before, during, or aftera surgical procedure. In other embodiments, the pigtail ID tag is addedto an electrode by the manufacturer prior to use. In embodiments, thepigtail ID tag is used to associate an electrode with a GUID connector(such as connector 365 as described below). A computing device, such asa tablet, PC, phone, watch, or other electronic means is used to scanthe pigtail ID tag during a surgical procedure and enter appropriateinformation into the system by a user, such as but not limited to:

-   -   Electrode type and attributes (model, lot, electrode numbers,        size, configuration, expiration date, and default montage)    -   Location and orientation in the brain including electrode depth    -   Color coding or other labeling from the manufacturer

The pigtail ID tag is then later scanned when connected to an amplifierof a GUID connecter to create an association between the electrode andconnector. All information gathered during the surgical procedure isautomatically associated with the GUID connector. Electrodes may bedisconnected from a first associated GUID connector (for example, when apatient needs to undergo an Mill scan) and the association procedure mayrepeated on any other appropriately sized GUID connector. In otherwords, the patient does not need to be connected to the same firstassociated GUID connector. All data associated with the pigtail ID tagfor the electrode would now be associated seamlessly to the new GUIDconnector. In some embodiments, the association is confirmed via agraphical display to the user. In embodiments where the pigtail ID tagis received pre-attached to the electrode directly from the manufacturer(instead of being added before, during, or after a surgical procedure),the pigtail ID tag already contains the electrode attribute informationlisted above and the information does not need to be entered by theuser. In some embodiments, the pigtail ID tag, or a similar ID tag, isused to identify any and all other accessories or devices attached tothe system, including but not limited to, a surgical stimulation probe,expansion headbox, and stimulation box.

FIG. 3F illustrates a second system 300 e for connection of at least oneelectrode (or at least one group of electrodes) to an amplifier of amedical device, in accordance with some embodiments of the presentspecification. As shown, the 4-element strip electrode 332 and the 8×8element grid electrode 334 are positioned on/within the patient's brain335. An electrode lead 360 from the 4-element strip electrode 332 isconfigured to be inserted into an adapter connector 362 for electricalconnection. In accordance with an aspect of the present specification,the electrode lead 360 carries a “pig tail” unique ID (GUID) tag 364.The adapter cable 340, emanating from and in electrical and/or datacommunication with the adapter connector 362, terminates into and is inelectrical and/or data communication with a connector 365. The connector365 is inserted into any of the appropriate sockets 352 on the amplifier366.

In some embodiments, the tag 364 is embedded into the electrode lead 360such that it may be read directly by the adapter connector 362. Thus, inaccordance with an aspect of the present specification, the adapterconnector 362 includes a reader to detect the GUID tag in the electrodelead 360 (which is inserted into the adapter connector 362) and acquirea plurality of information stored in the GUID tag 364 that is passedthrough the connector 365 to a software application associated with themedical device. Once the connector 365 is inserted into one of thesockets 352, the system 300 e recognizes that a new connector 350 hasbeen connected to the amplifier 354 and the unique ID tag 364 is readdirectly by the software application associated with the medical device.In embodiments, GUID data is communicated via the amplifier andprocessed by a software application running on the computing system towhich the amplifier is connected. In alternate embodiments, the softwareapplication resides on the amplifier itself. In embodiments, the uniqueID tag 364 is used to configure display and other settings usingknowledge of the geometry and type of the connector 365.

In alternate embodiments, the tag 364 is configured as a crimp, anadhesive label or an adhesive wrap around “flag” that requires a barcodereader to be read, for example. In this case the user may scan theelectrode (for the tag 364) and then scan the adapter connector 362 toassociate the two. In various embodiments, the tag 364 comprises a barcode, QR code or an RFID code.

Because the system 300 e essentially “reads” the unique ID tag 364 fromthe electrode 332 and because the ID is globally unique, the system 300e can use the unique ID to “look up” (within a database) requiredproperties of and information (such as, but not limited to,manufacturer, number of electrodes, geometry, materials, and any specialconsiderations) about the electrode 332 from the manufacturer andautomatically configure the system 300 e appropriately. The user wouldstill need to document the location of the electrode 332 on the surfaceof the brain, but all other steps are eliminated.

If the electrode 332 is removed from the connector 365 and inserted intoa different connector, the system 300 e will automatically read the IDtag 364 and perform the appropriate association without requiring userintervention. Also, it should be appreciated that the unique ID 364 fromthe electrode 332 is read whenever the connector 365 is moved orconnected to a different amplifier to resume data collection and displaywithout the need for manual configuration.

FIG. 3G is a flow chart showing steps in a method for using the secondembodiment of a system for connection of at least one electrode (or atleast one group of electrodes) to an amplifier of a medical device, inaccordance with some embodiments of the present specification. At step380, a 4-element strip electrode and/or an 8×8 element grid electrodeare positioned on or within the patient's brain. The electrode leademanating from the 4-element strip electrode is inserted into theadapter connector for electrical connection at step 382. A connector,which is in electrical and/or data communication with the adapterconnector via an adapter cable is inserted, at step 384, into anappropriate socket on an amplifier. Once the connector is inserted intoone of the sockets, the system recognizes that a new connector has beenconnected to the amplifier and automatically identifies or “reads” theelectrode that is connected in step 386. In embodiments, the tag may beread directly by the adapter connector. In alternate embodiments, theuser may scan the electrode for the tag and then scan the adapterconnector 362 to associate the two, where the tag may be a bar code, QRcode or an RFID code.

In various embodiments, the connector 365 is magnetically coupled to thesockets 352. In various embodiments, the connection between theconnector 365 and receiving sockets 352 is directionally independentsuch that the connectors are reversible about a horizontal plane. Inembodiments, the connector 365 may vary in size to optimally match thenumber of leads on the electrode.

It should be noted that in medical procedures, the electrodes areclassified in groups wherein the electrodes belonging to the same groupare of similar type and are deployed in a similar location. In EEGprocedures, the electrodes typically come in groups of 4, 5, 6, 8, 10and 16 electrodes, although other groupings are also used, wherein eachsuch group is targeted towards a specific part of the brain. Ifconnectors of the same size are used for all electrode groups, severalinput channels will go to waste in the case of connectors that aremapped to groups having fewer numbers of electrodes. To allow highutilization of input channels, in embodiments, the electrodes areorganized in small groups and the connectors are designed in differentsizes which provide the flexibility to support the electrode groups ofvarying sizes.

FIG. 4A illustrates connectors 410, 420, 430, 440 of different sizes. Asshown in FIG. 4A, connector 410 comprises an ID output pin 401 and a setof four output pins 402 which can support an electrode group comprisingup to four electrodes. Connector 420 comprises eight output pins 422 soin case the number of electrodes is more than four and less than orequal to eight, the user can deploy connector 420 instead of theconnector 410. Similarly, connector 430, having 12 output pins cansupport up to 12 electrodes and connector 440, having 16 output pins,can support up to 16 electrodes. Connectors 420, 430, and 440 alsoinclude ID output pins 421, 431, and 441 respectively. Instead of usingconnectors of a single size, the user can deploy connectors of multiplesizes, thereby reducing the space requirement in actual procedures. Allthe connectors have an ID output pin 401, 421, 431, 441 which is used toidentify the unique identity of a connector which the system will use tocorrelate, assign, or associate all electrodes mapped through aconnector with their correct channels. In some embodiments, referring toconnectors 420, 430, and 440, the output pins are grouped into groups offour channels. For example, connector 420 includes two four-pin groups422 a and 422 b of output pins 422, connector 430 includes threefour-pin groups 432 a, 432 b, and 432 c of output pins 432, andconnector 440 includes four four-pin groups 442 a, 442 b, 442 c, and 442d of output pins 442. A receiving socket is capable of accepting any ofthe connectors to be plugged in anywhere along its bank of inputs. Eachconnector needs only a single ID and the socket is configured toidentify any connector in any position.

In some embodiments, systems of the present specification include aconsolidator which functions as one single mass connector for connectinga multitude of electrodes. A consolidator comprises a single masstermination connector or connection plate to which a plurality ofconnectors, such as connector 300 of FIG. 3A, connector 320 of FIG. 3B,and connectors 410, 420, 430, 440 of FIG. 4A, are configured to beconnected. The consolidator is configured to be connected to or removedfrom an amplifier of a monitoring system as a single unit. In someembodiments, connectors of different sizes and having different numbersof output pins may be inserted into a consolidator simultaneously. Allunique ID (for example, GUID) data from each individual connector istransferred through the consolidator to the amplifier.

FIG. 4B illustrates a consolidator 450 for receiving a plurality ofconnectors, in accordance with some embodiments of the presentspecification. As shown, the consolidator 450 is a flat plate or moduleof a suitable insulating yet rigid material (such as, but not limitedto, plastic) with a plurality of openings or holes 452 cut therein thatattach to and correspondingly hold a plurality of connectors, such asthe connector 454. During operation, the connector 454 is partiallyinserted into the opening or hole 452 of the consolidator 450 to a point453 where a first portion 454 a (comprising a plurality of output pins)of the connector 454 protrudes below the consolidator 450 and a secondportion 454 b (comprising a handle portion) extends above theconsolidator 450.

The consolidator 450 may then be used to hold/contain a plurality ofconnectors for one side of an amplifier with a user inserting andremoving all connectors at once using the consolidator 450. In thiscase, “transfer” of the ID and other signal data does not need to happenthrough the consolidator 450 as in this embodiment the consolidator 450is a mechanical means of positioning multiple connectors so they may beinserted into and removed from the amplifier simultaneously, if needed.

FIG. 4C illustrates a consolidator 460 for receiving a plurality ofconnectors 454, in accordance with some embodiments of the presentspecification. As shown, the consolidator 460 is configured as a plateor module 461 comprising a plurality of male connector elements on afirst side 462 that are configured to be connected to connectorreceptacles on an amplifier (not shown). The consolidator 460 alsoincludes a plurality of female receptacles or sockets 464 on a secondside 463, opposite the first side, for receiving male connector elementsof connectors 454. The male connector elements on the consolidator 460are similar to, or match, the male connector elements of the connectors454 and the female receptacles on the amplifier are similar to, ormatch, the female receptacles 464 on the consolidator 460. During use,the connectors 454 are first inserted into the consolidator 460, byconnecting the male connector elements of the connectors 454 with thefemale receptacles or sockets 464 of the consolidator, and then theconsolidator 460 is subsequently inserted into the amplifier byconnecting the male connector elements of the consolidator 460 with thefemale receptacles of the amplifier (shown in FIG. 4D). In this manner,the consolidator 460 connects to or detaches from the amplifier as asingle unit. In this embodiment, each electrical connection in theconsolidator 460 passes through from each receptacle 464 to theamplifier. Thus, the connectors 454 make electrical contact with thefemale receptacles 464 and the electrical connection is passed throughthe consolidator 460 to male connector elements that insert into thefemale receptacles on the amplifier. In some embodiments, theconsolidator is in electrical and/or data communication with both theconnectors and the amplifier.

Also shown in FIG. 4C is an actual implementation of the system shown inFIGS. 3D and 3F. In an embodiment, a plurality of sockets 464 eachcontains 6 contact pins, two of which are used to communicate electrodedata. Thus, in this embodiment shown, two sockets 464 are used to read 8channels. In an example with a 2×5 grid (a 10-channel grid), threeblocks would be needed (for a total of 12 channels available as 6 areused for communicating electrode data), although only 10 pins/channelswould be employed. In embodiments, multiple sizes of connectors 454 canbe employed.

FIG. 4D illustrates a consolidator 470 for receiving a plurality ofconnectors, in accordance with other embodiments of the presentspecification. The consolidator 470 is housed in a bracket 475 for datacommunication with a third party device, in accordance with someembodiments of the present specification. Each consolidator 470 may behoused in a bracket 475 wherein the bracket enables connection to athird party device either through passive or active (amplified) means.Thus, the signals may be sent directly to a third party device. Inaddition, bracket 475 comprises two bracket connectors 476 that may beplaced in electrical communication with a third party device. In oneembodiment, the consolidator 470 comprises male connector elements andfemale receptacles, similar to the consolidator 460 of FIG. 4C, toconnect to the amplifier 480, and the bracket connectors 476 are inelectrical communication with the amplifier and third party devicethrough the male connector elements and female receptacles of theconsolidator 470. In another embodiment, the bracket 475 is removablefrom the consolidator 470 and comprises or supplies a plurality of maleconnector elements on one side configured to connect with the connectorreceptacles on the amplifier. Further bracket 475 comprises femalereceptacles on the other side for receiving the male connector elementsof the consolidator 470. Thus, in this embodiment, bracket 475 acts as aremovable “bridge” from the consolidator 470 to the amplifier thatenables connection of the consolidator to a third party device obviatingthe need for disconnection. Also, in this embodiment, bracket connectors476 are in electrical communication directly with the amplifier andthird party device through the male connector elements and femalereceptacles of the bracket 475.

It should be appreciated that in both embodiments of FIGS. 4C and 4D,the “transfer” of both ID data and signal data is a seamless directpin-to-pin pass through on the connector. The system will see the samedata on the same line as it would if the connector where plugged indirectly to the amplifier.

In embodiments, connectors and the corresponding receiving socketcomprise mechanisms to ensure that there is no misalignment when theconnector is coupled with the receiving socket. In embodiments, multipleconnector types are provided to be used with different kinds ofproducts. In embodiments, certain inputs of the connectors are providedwith enhanced capabilities, such as lower noise, higher offset voltagetolerance or differential inputs, and the user is required to pluginputs needing such capabilities into a subset of connector locations.In some embodiments, not every input has the same requirements and theamplifier or signal processing needed is different for those inputs. Ifthe physical connector is inserted into an input whose channel did notsupport the function, then the system could notify the user to choose adifferent input that did support the function. In some embodiments, thesystem includes a subset of channels that have more capability and couldaccept either normal or enhanced inputs. These channels would stillsupport non-enhanced inputs to allow better channel utilization. In someembodiments, SpO₂ or otherwise not supported input types are configuredto a small number of inputs. In other embodiments, pressure inputs, forexample, plug into a different bank of identified connectors set up forpressure measurements instead of voltage measurements.

In embodiments, apart from the unique ID, certain other information isstored in the connectors, such as the authentication information,production dates of the connector and the electrodes corresponding toeach connector.

FIG. 5A shows an exemplary illustration of an eight channel connector510 deployed to support an eight input depth electrode 505 in an EEGprocedure. As shown in FIG. 5A, the connector 510 comprises an ID outputpin 501 and a set of eight output pins 502 which means that theconnector 510 can support up to eight electrodes. The connector 510 iscoupled to an eight input depth electrode 505 through a set ofelectrical leads 506. In some embodiments, the depth electrode 505 iscoupled to the connector 510 via one or more intermediate connectors503. The intermediate connectors 503 provide the system with greaterflexibility when dealing with the limited geometry involved in surgicalprocedures. In other embodiments, the system does not includeintermediate connectors and the electrodes couple directly with theconnector and the ID information is very specific to the electrode (forexample, electrode caps, respiratory belts, and EKG inputs). The depthelectrode 505 is positioned in the cortex area of the brain 507. Theconnector 510 has a unique ID (identity) stored in an inbuilt memory. Inan embodiment, the unique ID comprises a 128 bit GUID and is stored inan EPROM (erasable programmable read-only memory) device in theconnector 510. When the connector 510 is plugged in a receiving socket,the system reads the ID information from the EPROM memory device throughID output pin 501 and establishes the identity of the eight input depthelectrode 505 coupled to the connector 510. The system accordinglyconfigures itself (and reconfigures itself if the connectors are removedand re-inserted in another position) to correlate or associate thecorrect inputs of the depth electrode 505 with their corresponding inputchannels.

FIG. 5B shows a detailed illustration of the eight channel connector 510deployed to support an eight input depth electrode 505 in an EEGprocedure as depicted in FIG. 5A. As shown in FIG. 5B, the connector 510is coupled to the depth electrode 505 through an electrical lead 506. InFIG. 5B, the intermediate connector 503 comprises a ring contactconnector which is configured to receive a wire 516 with multiple ringcontacts such that each ring contact is coupled to one of a plurality ofinputs of the eight input depth electrode 505. The wire 516 comprises aset of ring contacts 509 such that as the wire 516 is inserted into theintermediate connector 503, each of these ring contacts 509 establishesan electrical contact with one of the eight ring shaped receptacles 503a in the intermediate connector 503. The electrical lead 506 comprisesmultiple conductors 518 inside it wherein each such conductor 518 actsas a separate electrical communication channel between the depthelectrode 505 and eight channel connector 510. An exploded view of thelead 506 is shown as 506 a which comprises eight different electricalconductors 518. As described above, the intermediate connector 503 usesring contact receptacles and provides the system with greaterflexibility in dealing with electrodes, such as the depth electrode 505.In some embodiments, connector 503 is used in different configurations.

FIG. 6 shows a 64 electrode grid 600 deployed on a brain 650 using theconnectors disclosed in this specification. As shown in FIG. 6, theelectrode grid 600 comprises 64 electrodes which are deployed on variousportions of the brain 650. The electrode grid 600 is deployed through aninvasive surgery. The 64 electrodes are arranged in four groups witheach group comprising 16 electrodes. The first group of 16 electrodes iscoupled to a 16 channel connector 610 through a first electrical lead611. The second group of 16 electrodes is coupled to a 16 channelconnector 620 through a second electrical lead 621. The third group of16 electrodes is coupled to a 16 channel connector 630 through a thirdelectrical lead 631. The fourth group of 16 electrodes is coupled to a16 channel connector 640 through a fourth electrical lead 641. In someembodiments, each lead 611, 621, 631, 641 is connected to its respectiveconnector 610, 620, 630, 640 via an intermediate connector 615. Theintermediate connectors 615 provide the system with greater flexibilitywhen dealing with the limited geometry involved in surgical procedures.Each of the connectors 610, 620, 630 and 640 has a unique ID which isstored in an inbuilt memory in the corresponding connector. In anembodiment, the ID of various connectors comprises a 128 bit GUID whichcan be read by the system when the corresponding connector is plugged ina receiving socket of the system control device. Connector 610 comprisesa first GUID 612, connector 620 comprises a second GUID 622, connector630 comprises a third GUID 632 and connector 640 comprises a fourth GUID642. When any of the connectors 610, 620, 630 and 640 is plugged in areceiving socket, the system reads its GUID information and establishesthe identity of connector. Subsequently, the system configures itself tocorrelate or associate the electrodes mapped to the correspondingconnector with the correct input channels.

In some embodiments, electrode identification is used to assist withco-registration between electrode location in the brain andidentification of that electrode in volumetric data sets with MRI, CT,or other imaging studies. Co-registration enables rapid visualization ofacquired data and EEG data (raw or analyzed) on the co-registeredvolumetric data set.

It should be appreciated that “co-registration” is an act of aligning in3-D space specific data sets so they may be overlaid and viewedtogether. For example, CT and MRI images of the head and brain may be“co-registered” so both structural (CT) and soft tissue (MRI) data maybe viewed in the same image. By using the ID of the electrode andassociating it with a certain location where it was placed in/on thebrain, a software application may be used to automatically detect whichelectrode in the image is associated with which data set being displayedon a review workstation (displaying EEG raw waveform data, for example)or may also be further analyzed such that, for example, seizure activityassociated with a specific electrode may be displayed on a 3-D image asa color or intensity. To accomplish this, a general location of theelectrode needs to be input by the user (for example, ID 12345678 wasplaced at coordinates X,Y,Z) and then the software application canlocate potential matching electrodes in the image through image analysisand automatically assign electrode numbers (and associated waveformdata).

In some embodiments, the systems and methods of the presentspecification provide stimulation and functional mapping tied to 3Dvisualization. Once an electrode location is identified in a 3-D image(for example could be a fused MRI CT image from the patient or arepresentative 3-D model of the skull and brain) then the electrode inthe 3-D model may be clicked on and used as part of the softwaregraphical user interface (GUI) to guide the process of corticalstimulation and functional mapping. Conventionally, these are cumbersomeprocedures involving a 2-D display showing multiple EEG waveforms andpossibly moving leads on a “stimulator” used to deliver electricalcurrent to the brain during the procedure.

The procedure itself is used to “map” portions of the brain to determineif it is safe to remove the section of the brain causing seizures ornot. The basic steps, as known to persons of ordinary skill in the artcomprise: a) using extra-cranial EEG (surface electrodes) perform astudy to determine the approximate location within the brain whereseizures occur, b) implant electrodes within or on the surface of thebrain to improve the resolution of the recording, d) take patient off ofmedication to induce more seizures, e) record seizures and determinewhere the suspected location of the seizure source is, f) perform afunctional mapping procedure if the source is close to an importantlocation (such as, for example, motion, sensory, speech), and g) basedupon the results of functional mapping, determine if the brain tissuecausing the seizure may be removed or otherwise safely treated.

To perform the mapping, electrical current is passed between selectedcombinations of electrodes while specific tasks are performed by thepatient, the results of which are recorded and analyzed. The electricalcurrent (stimulation) has the effect of temporarily paralyzing the braintissue between the electrodes emulating what the result would be if thatbrain tissue was removed. Normal function returns when the stimulationis stopped.

Since contemporary electrode placement techniques typically includecombinations of sEEG (depth electrodes) and strip/grid (brain surface)electrodes, the prior art or conventional 2-D planar visualizationproblem (grid and strip electrodes on the surface of the brain) hasbecome a more complex volumetric problem. Volumetric visualizationenables an operator to know how to stimulate between two sets ofelectrodes in the brain, where in the brain should the stimulation beapplied and the ability to have the system easily, rapidly, andaccurately associate electrodes found in an image with the actual EEGdata coming from the electrode (or cortical stimulation provided throughit). Having the electrode ID known to the system enables automaticassociation in 3-D images of electrode to data.

Accordingly, in one embodiment, the system generates a three dimensionalimage having a plurality of electrodes associated with pixel positionsin three dimensional image. The system further provides a graphical userinterface configured to receive a user input designating at least one ofthe plurality of pixel positions in the three dimensional image. Uponreceiving the user input designating at least one of the plurality ofpixel positions, the system determines the electrode associated withselected pixel position and accesses the unique identification codeassociated with the determined electrode. The system then uses theunique identification code to access data, stored in a local or remotememory, to acquire data associated with the unique identification codeand, therefore, with the selected electrode. It should be appreciatedthat, in one embodiment, the system stores electrode-specific data inassociation with a unique identification code and further storesassociations of the unique identification with particular electrodes.

FIG. 7 shows a flowchart illustrating the steps involved in oneembodiment of configuring a system using the connectors disclosed in thepresent specification. As shown in FIG. 7, at step 710, the electrodesare arranged into a plurality of groups such that electrodes of similartype and deployment location are included in the same group. Theelectrodes in the same group have similarities in terms of their inputchannel and positioning and are coupled to the same connector in aspecific sequence.

At step 720, based on the number of electrodes in each group, aconnector of appropriate size is selected for each electrode group. Theconnector should have a number of input channels greater than or equalto the number of electrodes in the electrode group supported by it. Atstep 730, electrodes are connected with the corresponding connectors. Atstep 740, the information related to the order in which the electrodesare coupled to each connector is provided to the control unit. At step750, the connectors are connected with a receiving socket in the controlunit of the medical device. At step 760, the system establishes theidentity of all connectors using the unique ID information stored ineach connector. At step 770, the system configures itself to correlateor associate each electrode with its corresponding input channel in thecontrol unit. At step 780, the system set up is complete and procedurecan be started. In some embodiments, step 740 is executed after step 750when the system requests for information about the electrode groupcoupled with a connector at a run time after a connector is inserted inthe receiving socket and the user subsequently provides this informationto the control unit.

FIG. 8A shows a control unit 800 of a 256 channel neuromonitoring andneurodiagnostics EEG system having receiving sockets 801 which areconfigured to receive multiple connectors. As shown in FIG. 8A, thecontrol unit 800 of the medical system comprises a plurality ofreceiving sockets 801. The control unit 800 comprises 256 input channelsand can therefore support the same number of electrodes. In control unit800, the receiving sockets 801 corresponding to the 256 input channelsare divided into eight columns such that each column corresponds to 32input channels. The control unit 800 is coupled to a data acquisitionsystem through cable 810. FIG. 8B shows the medical system of FIG. 8Abeing used for monitoring the neurological state of a patient. As shownin FIG. 8B, a plurality of electrodes 805 are positioned over the headof a patient 820 to monitor the electrical activity of brain. Theelectrodes 805 are arranged into groups such that each group compriseselectrodes of same type. These multiple groups of electrodes are coupledto separate connectors, such as the connectors 410, 420, 430, and 440shown in FIG. 4. The electrodes 805 are coupled to connectors 802 thougha plurality of electrical leads 806. The connectors 802 are coupled tothe receiving sockets 801 as shown in FIG. 8B. Each of the connectors802 has a unique identity which is stored in the connector in the formof a GUID. The receiving sockets 801 are configured to read the GUIDinformation of each connector and establish its identity. Afterestablishing the identity of connectors 802, the control unit 800configures the system to correlate or associate each of the electrodes805 with its corresponding input channel in the control unit 800.

In some embodiments, the system provides an automatic ‘sanity’ check toverify that the type and configuration of electrode connected,particularly a grid electrode, is what the operator assigned. In someembodiments, the system performs checks to confirm the electrode isconnected, that it is the correct electrode, and to confirm theelectrode shape and configuration. U.S. Patent Provisional ApplicationNo. 62/758,320, also by the Applicant of the present specification, isherein incorporated by reference in its entirety.

For example, an 8×8 grid electrode has 4 leads coming off of it, eachlead carrying signals from 16 electrodes within one (4×4) quadrant ofthe grid. Each lead is connected to a single connector having anassociated unique ID. As each connector is attached to the amplifier,the user needs to identify a) whether it is part of the 8×8 grid and b)what quadrant it represents. In accordance with some aspects of thepresent specification, the system provides safety or sanity check thatcan be performed automatically by the system once all of the connectionshave been made. The system will know that it is an 8×8 grid and the userassigned quadrants for each 4×4 connector within the grid, and can usethis information to verify that the association was performed correctly.

In some embodiments, such as that of FIG. 3E, each lead coming directlyfrom the electrode (and preferably created at the time of manufacture)includes a unique ID that is passed through directly to the amplifier.In this case, there is no user association needed to assign theconnector to a specific quadrant or to even determine that it is an 8×8grid as that would be automatic, but the system still performs thesanity check to ensure labeling from the manufacturer is correct.

Once connected and assigned, the system analyzes impedance, waveform,and stimulation data to assess if the operator has performed theassociation correctly. In some embodiments, the system measuresimpedance to determine if an electrode is connected. Based on theimpedance measurements, the system removes traces for the electrodeand/or generates a warning to the user if the electrode is not detected.In one embodiment, an 8×8 electrode array includes four 16 conductorpigtail connectors attached to it and existing a patient's skull. Eachpigtail connector needs to be connected to a GUID by an operator andassigned a grid type/location by the operator (assuming no other meansof auto ID has been implemented, such as the pigtail ID tag describedabove). Once all four pigtails have been assigned to a quadrant of the8×8 array, a software application of the system determines if thesignals “make sense” for that specific configuration and if not, awarning indicator is presented to the operator. For example, in anembodiment, a software application of the system verifies the shape andfunction of an electrode by stimulating and recording on all channels,then reverse calculating the geometry to verify it matches what thesystem believes is connected. In some embodiments, the system promptsthe user when it detects an unknown connector is attached to the system.

In various embodiments, the connectors and receiving sockets of thesystems of the present specification are ‘keyed’ in such a way so thatthe connectors can be inserted into the receiving sockets at severallocations, but cannot be inserted backwards or at an invalid location.For example, in some embodiments, a connector is configured such that itcan be inserted in a top-up or bottom-up orientation, with respect toits horizontal axis, into a receiving socket, but only at discretelocations in the receiving socket. In an embodiment, the receivingsocket is configured to detect the orientation of the connector and theID of the connector. In another embodiment, the pins are duplicated onboth top and bottom sides of the connector. Some embodiments of keyedconnector and receiving socket connections are described with referenceto FIGS. 9A through 11 below and are intended to be exemplary in natureand not limiting with respect to the present specification.

FIG. 9A and FIG. 9B show an illustration of exemplary embodiments ofconnectors 910, 930 and receiving sockets 915, 935. The connectors 910,930 and receiving sockets 915, 935 are configured with design featuresto allow for only one orientation during connection. Referring to FIG.9A, connector 910 includes a pair of ‘keys’ or ridges 911 at its topsurface with align with notches 916 in the receiving socket 915 toensure the connector 910 is inserted correctly into the receiving socket915. In embodiments, the connector 910 has one design element, such asthe ridge 911, for every four signal input pins and the receiving socket915 has multiple notches, such as the notch 916, such that the connector910 can be received at multiple locations along the receiving socket 915occupying 4, 8, 12, or 16 input sockets. In the above embodiment, theconnector 910 comprises one design element or ridge 911 and thereceiving socket has one notch 916 for every four number of signal inputpins. In other embodiments, the number of signal input pinscorresponding to each design element or ridge 911 is of a differentmultiple, for example, 5, 6, or 7, and the notch 916 of the receivingsocket 915 is configured accordingly to support the correspondingstructure of the connector 910.

Referring to FIG. 9B, the connector 930 is provided with an asymmetricdistribution of pins 931 which corresponds with a matching asymmetricdistribution of receptacles 936 on the receiving socket 935 to ensurethe connector 930 is inserted correctly into the receiving socket 935.As depicted in FIG. 9B, an ID output pin 932 on the connector 930 ispositioned separate from the set of pins 931 and aligns with an ID inputsocket 937 separate from the set of receptacles 936 on the receivingsocket 935 to ensure proper alignment and identification.

FIG. 10 illustrates a connector 1000 which can be used in dualorientations in accordance with an embodiment of the presentspecification. A first side 1010 a and a second side 1010 b of aconnector 1000 are depicted in FIG. 10. In an exemplary embodiment, theconnector 1000 comprises four output signal pins 1001, 1002, 1003 and1004 and two ID pins 1005 and 1006. The first side 1010 a comprises theoutput signal pins 1001 and 1002 and the ID pin 1005. The second side1010 b comprises the output signal pins 1003 and 1004 and the ID pin1006.

The connector 1000 can be coupled to the receiving unit or socket 1030in two different orientations. A first front-on view 1020 a depicts thefirst side 1010 a of the connector 1000 oriented to a ‘top’ surface 1021and the second side 1010 b oriented to a ‘bottom’ surface 1022. View1020 a of the connector 1000 depicts the positioning of the variousoutput signal pins and the ID pins in a first orientation, with outputsignal pins 1001 and 1002 and ID pin 1005 positioned on said ‘top’surface 1021 and output signal pins 1003 and 1004 and ID pin 1006positioned on said ‘bottom’ surface 1022. A second front-on view 1020 bdepicts the second side 1010 b of the connector 1000 oriented to said‘top’ surface 1021 and the first side 1010 a oriented to said ‘bottom’surface 1022. View 1020 b depicts the positioning of the various outputsignal pins and the ID pins in a second orientation, with output signalpins 1003 and 1004 and ID pin 1006 positioned on said ‘top’ surface 1021and output signal pins 1001 and 1002 and ID pin 1005 positioned on said‘bottom’ surface 1022. In the second view 1020 b, the connector 1000 isrotated 180 degrees about its horizontal axis or Z axis 1040 as comparedto its position in the first view 1020 a.

As shown in FIG. 10, the first and the second views 1020 a, 1020 b ofconnector 100, respectively depicting first and second configurations,are horizontally flipped images of each other, about the Z axis 1040,and hence it is not possible to distinguish one orientation from anotherfrom the physical structure. In the disclosed system, the receiving unit1030 detects the orientation of the connector 1000 based on thepolarities of the ID pins. In FIG. 10, the two ID pins 1005, 1006 haveopposite polarities such that ID pin 1005 has a positive polarity and IDpin 1006 has a negative polarity. In other embodiments, ID pin 1005 hasthe negative polarity and ID pin 1006 has the positive polarity. Whenthe connector 1000 is inserted in the receiving unit 1030, depicted in afront-on view 1030 a, the various output signal pins and the ID pins ofthe connector 1000 establish contact with the various input matingsockets or pins in the receiving unit 1030. When the connector 1000 isinserted in the receiving unit 1030 in the first orientation, as shownin view 1020 a, the ID pin 1005 establishes contact with the ID inputpin 1008 and the ID pin 1006 establishes contact with the ID input pin1009 of the receiving unit 1030. Alternatively, when the connector 1000is inserted in the receiving unit 1030 in the second orientation, asshown in view 1020 b, the ID pin 1006 establishes contact with the IDinput pin 1008 and the ID pin 1005 establishes contact with the ID inputpin 1009 of the receiving unit 1030. The system reads the respectivepolarities of the ID pins in contact with the ID inputs sockets 1008 and1009 and hence detects the orientation of the connector 1000 as insertedin the receiving socket 1030. Subsequently, the system reconfiguresitself to automatically map each input with its corresponding inputchannel.

The system disclosed in FIG. 10 uses two ID pins with oppositepolarities. In some embodiments, the polarities of the two ID pins arenot opposite and the two ID pins are just maintained at differentvoltage levels and the identity of the ID pins is detected based on thesignal/voltage received from the corresponding ID pins. Once the systemidentifies and distinguishes the two ID pins, the orientation of theconnector as inserted in the receiving socket is detected. The systemdisclosed in FIG. 10 comprises four output signal pins, however, inother embodiments, the number of output signal pins present in theconnector is different, such as less than 4 or greater than 4, including5, 6, 7, or more.

FIG. 11 illustrates a connector 1100 which can be used in dualorientations in accordance with another embodiment of the presentspecification. A first side 1110 a and a second side 1110 b of aconnector 1100 are depicted in FIG. 11. The connector 1100 comprisesfour output signal pins 1101, 1102, 1103 and 1104 and two ID pins 1105and 1106. The first side 1110 a comprises the output signal pins 1101and 1102 and the ID pin 1105. The second side 1110 b comprises theoutput signal pins 1103 and 1104 and the ID pin 1106.

The connector 1100 can be coupled to the receiving unit or socket 1130in two different orientations. A first front-on view 1120 a depicts thefirst side 1110 a of the connector 1100 oriented to a ‘top’ surface 1121and the second side 1110 b oriented to a ‘bottom’ surface 1122. View1120 a of the connector 1100 depicts the positioning of the variousoutput signal pins and the ID pins in a first orientation, with outputsignal pins 1101 and 1102 and ID pin 1105 positioned on said ‘top’surface 1121 and output signal pins 1103 and 1104 and ID pin 1106positioned on said ‘bottom’ surface 1122. A second front-on view 1120 bdepicts the second side 1110 b of the connector 1100 oriented to said‘top’ surface 1121 and the first side 1110 a oriented to said ‘bottom’surface 1122. View 1120 b depicts the positioning of the various outputsignal pins and the ID pins in a second orientation, with output signalpins 1103 and 1104 and ID pin 1106 positioned on said ‘top’ surface 1121and output signal pins 1101 and 1102 and ID pin 1105 positioned on said‘bottom’ surface 1122. In the second view 1120 b, the connector 1100 isrotated 180 degrees about its horizontal axis or Z axis 1140 as comparedto its position in the first view 1120 a.

When the connector 1100 is inserted in the receiving unit 1130, thevarious output signal pins and the ID pins of the connector 1100establish contact with the various mating sockets or pins in thereceiving unit 1130. In the system disclosed in FIG. 11, the receivingunit 1130, shown in a front-on view 1130 a, detects the orientation ofthe connector 1100 based on the location of the ID pins 1105 and 1106.When the connector 1100 is inserted in the receiving unit 1130 in thefirst orientation, as shown in view 1120 a, the ID pin 1105 establishescontact with the ID input pin 1109 a and the ID pin 1106 establishescontact with the ID input pin 1109 b of the receiving unit 1130.Alternatively, when the connector 1100 is inserted in the receiving unit1030 in the second orientation, as shown in view 1120 b, the ID pin 1105establishes contact with the ID input pin 1108 a and the ID pin 1106establishes contact with the ID input pin 1108 b of the receiving unit1130. The system verifies the positions of the ID pins 1105 and 1106 anddetects the orientation of the connector 1100 as inserted in thereceiving socket 1130 based on these positions. Subsequently, the systemreconfigures itself to automatically map each input with itscorresponding input channel.

The foregoing is merely illustrative of the principles of thedisclosure, and the systems, devices, and methods can be practiced byother than the described embodiments, which are presented for purposesof illustration and not of limitation. It is to be understood that thesystems, devices, and methods disclosed herein, while shown for use inneuromonitoring and neurodiagnostics procedures may be applied tosystems, devices, and methods to be used in other types of medicalprocedures for monitoring or treatment of diseases.

Variations and modifications will occur to those of skill in the artafter reviewing this disclosure. The disclosed features may beimplemented, in any combination and sub-combination (including multipledependent combinations and sub-combinations), with one or more otherfeatures described herein. The various features described or illustratedabove, including any components thereof, may be combined or integratedin other systems. Moreover, certain features may be omitted or notimplemented.

Examples of changes, substitutions, and alterations are ascertainable byone skilled in the art and could be made without departing from thescope of the information disclosed herein. All references cited hereinare incorporated by reference in their entirety and made part of thisapplication.

What is claimed is:
 1. A system for neuromonitoring comprising: aplurality of electrode groups, wherein each group of the plurality ofelectrode groups comprises electrodes, wherein each of the electrodes ineach group has at least one of a similar monitoring functionality typeor a similar deployment location and wherein each of the plurality ofelectrode groups has at least one electrode group lead; a plurality ofconnectors, wherein each of the at least one electrode group leads iscoupled to at least one connector of the plurality of connectors andwherein each of the electrode group leads and/or each of connectors ofthe plurality of connectors are electronically associated with a uniqueidentification code; and, a control unit comprising at least onereceiving unit configured for receiving the plurality of connectors,wherein the control unit is configured to determine at least one of theunique identification code of each connector of the plurality ofconnectors or the unique identification code of each of the at least oneelectrode group leads and to associate each electrode in the pluralityof electrode groups with a corresponding input channel in the controlunit based on at least one of the unique identification code of eachconnector or the unique identification code of each of the at least oneelectrode group leads.
 2. The system of claim 1, wherein said uniqueidentification code is in a 128 bit GUID format.
 3. The system of claim1, wherein said at least one receiving unit comprises a plurality ofinput sockets configured to receive one or more connectors of saidplurality of connectors.
 4. The system of claim 3, wherein said one ormore connectors are configured to be coupled to any of the plurality ofinput sockets of said at least one receiving unit.
 5. The system ofclaim 1, wherein the control unit is configured to determine at leastone of the unique identification code of each connector of the pluralityof connectors or the unique identification code of each of the at leastone electrode group leads by receiving, via each connector of theplurality of connectors, data indicative of at least one of the uniqueidentification code of each connector of the plurality of connectors orthe unique identification code of each of the at least one electrodegroup leads.
 6. The system of claim 1, wherein the control unit isconfigured to receive, via each connector of the plurality ofconnectors, data indicative of at least one of the unique identificationcode of each connector of the plurality of connectors or the uniqueidentification code of each of the at least one electrode group leadsthrough a direct pin-to-pin electrical pass through.
 7. The system ofclaim 1, wherein the control unit is configured to determine at leastone of the unique identification code of each connector of the pluralityof connectors or the unique identification code of each of the at leastone electrode group leads by receiving, via at least one connector ofthe plurality of connectors, data indicative of at least one of theunique identification code of each connector of the plurality ofconnectors or the unique identification code of each of the at least oneelectrode group leads.
 8. The system of claim 1, wherein the controlunit is configured to receive, via each connector of the plurality ofconnectors, data indicative of at least one of a production date orauthentication data.
 9. The system of claim 1, wherein the control unitis configured to receive, via each connector of the plurality ofconnectors and through a direct pin-to-pin electrical pass through, dataindicative of at least one of a production date of the plurality ofconnectors or the electrodes or authentication data.
 10. The system ofclaim 1 wherein said connector has a designated output pin which isconfigured to transmit information related to the unique identificationcode to said control unit.
 11. The system of claim 10, wherein dataindicative of the unique identification code is stored in a memoryassociated with the designated output pin.
 12. The system of claim 1,wherein data indicative of the unique identification code comprises abar code or a radio frequency code (RFID).
 13. The system of claim 1,wherein data indicative of the unique identification code is storedusing at least one pin configured as at least one dip switch comprisingat least one resistor.
 14. The system of claim 1, wherein each connectorof the plurality of connectors is configured to be inserted in the atleast one receiving unit in at least two different orientations.
 15. Thesystem of claim 1, wherein each connector of the plurality of connectorscomprises at least two designated output pins, each of which beingconfigured to convey data indicative of the unique identification codeand an orientation of a connector of the plurality of connectors. 16.The system of claim 15, wherein the at least two designated output pinsare configured to be at different polarities or at different voltagelevels to indicate the orientation of the connector of the plurality ofconnectors.
 17. The system of claim 15, wherein a physical position ofthe at least two designated output pins is different in each of the atleast two different orientations.
 18. The system of claim 1, furthercomprising a rigid connector plate, wherein the connector platecomprises a plurality of openings, each opening of the plurality ofopenings being configured to receive each connector of the plurality ofconnectors, and wherein each opening of the plurality of openings isseparated from an adjacent opening of the plurality of openings by aportion of the connector plate.
 19. The system of claim 18, wherein eachconnector of the plurality of connectors is partially positioned in eachopening of the plurality of openings such that a first end of eachconnector extends outward from a first surface of the connector plateand a second end, opposing the first end, of each connector extendsoutward from a second surface of the connector plate, wherein the secondsurface opposes the first surface.
 20. The system of claim 1, furthercomprising a rigid connector plate, wherein the connector platecomprises a plurality of sockets, each socket of the plurality ofsockets being configured to receive each connector of the plurality ofconnectors, and wherein each socket of the plurality of sockets isseparated from an adjacent socket of the plurality of sockets by aportion of the connector plate and is configured to electrically connectto a corresponding socket in the at least one receiving unit.
 21. Thesystem of claim 1, wherein the control unit is further configured todetermine at least one of authentication data or data indicative of aproduction date of the plurality of connectors or the electrodes byreceiving, via at least one connector of the plurality of connectors,data indicative of the at least one of authentication data or dataindicative of the production dates of the plurality of connectors or theelectrodes.
 22. The system of claim 1, wherein the control unit isconfigured to generate data indicative of, or associated with, athree-dimensional image.
 23. The system of claim 22, wherein thethree-dimensional image comprises a plurality of pixel positions andwherein at least one of the plurality of pixel positions is associated,in a memory, with at least one of the electrodes.
 24. The system ofclaim 23, wherein the control unit is configured to receive dataindicative of a user input selecting at least one of the plurality ofpixel positions of the three-dimensional image and is configured toidentify at least one electrode associated with the selected at leastone of the plurality of pixel positions based on the user input.
 25. Thesystem of claim 24, wherein the control unit is further configured todetermine data associated with the identified at least one electrode byusing the unique identification code associated with the at least oneelectrode.
 26. The system of claim 1, wherein the control unit isconfigured to automatically populate at least one graphical userinterface with data indicative representative of each of the electrodesbased on the unique identification codes.
 27. The system of claim 26,wherein the control unit is configured to automatically update datadisplayed in the at least one graphical user interface with updated dataindicative representative of each of the electrodes based on the uniqueidentification codes after one or more of the electrodes is moved ordisconnected and reconnected to the at least one receiving unit.
 28. Thesystem of claim 1, wherein the control unit is configured to receivedata indicative of a user selection of a trace displayed on a graphicaluser interface, wherein, upon receiving data indicative of the userselection of the trace, the control unit is configured to trigger avisual indicator positioned in physical proximity to or association withone of the electrodes that acquired data associated with said trace. 29.The system of claim 28, wherein the visual indicator is at least one ofa light positioned on the one of the electrodes, a light positioned on aconnector of the plurality of connectors in data communication with theone of the electrodes, or a light positioned on a lead attached to theone of the electrodes.
 30. The system of claim 1 wherein said electrodesare configured in groups of 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 or16 electrodes.
 31. The system of claim 1 wherein said system isconfigured to perform at least one of an electroencephalography,electrocardiogram, electromyography, polysomnography, or intraoperativeneural monitoring procedure.
 32. The system of claim 1, wherein theunique identification code associated with each said electrode grouplead is stored in association with each electrode group lead, andwherein the unique identification code is configured as any one of acrimp, an adhesive label or an embedded code on each electrode grouplead.
 33. The system of claim 1, wherein each connector of the pluralityof connectors further comprises a value and wherein the value isrepresentative of a number of permissible uses of the connector of theplurality of connectors.
 34. The system of claim 33, wherein the valueis indicative of a maximum number of sterilization cycles of theconnector of the plurality of connectors and wherein the maximum numberof sterilization cycles is equal to, or less than,
 20. 35. The system ofclaim 1, wherein the control unit is configured to access a valueassociated with each connector of the plurality of connectors, whereinthe value is indicative of a maximum number of sterilization cycles ofthe connector of the plurality of connectors and wherein the maximumnumber of sterilization cycles is equal to, or less than, 20.